DUAC® Early Onset Efficacy Study in Japanese Subjects

• ClinicalTrials.gov Identifier: NCT02557399
• Recruitment Status: Completed
• First Posted: September 23, 2015
• Results First Posted: February 15, 2018
• Last Update Posted: August 20, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Acne Vulgaris
• Interventions: Drug: Duac® fixed dose combination gel; Drug: ADA 0.1% gel; Drug: CLDM 1% gel
• Enrollment: 350

Participant Flow

Recruitment Details	DUAC® (clindamycin phosphate 1.2 percent [%] + benzoyl peroxide 3%) is the registered product of GlaxoSmithKline. This study was conducted between 07 October 2015 and 17 February 2016 in which 349 participants were randomized.
Pre-assignment Details

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 finger tip unit (FTU) about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Period Title: Overall Study
Started	172	177
Completed	165	169
Not Completed	7	8
Reason Not Completed
Adverse Event	6	5
Protocol Violation	0	1
Protocol-defined stopping criteria	0	1
Withdrawal by Subject	1	1

Baseline Characteristics

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%	Total
Arm/Group Description		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity equal to about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity equal to about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.	Total of all reporting groups
Overall Number of Baseline Participants		172	177	349
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	172 participants	177 participants	349 participants
		20.3 (5.91)	19.8 (4.90)	20.0 (5.42)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	172 participants	177 participants	349 participants
	Female	97 56.4%	110 62.1%	207 59.3%
	Male	75 43.6%	67 37.9%	142 40.7%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	172 participants	177 participants	349 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	172 100.0%	177 100.0%	349 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Percent Change in Total Lesion Counts (TLs) From Baseline to Week 2
Description	The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-inflammatory lesions were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Time Frame	Baseline (Day 1) and Week 2

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) population comprised of all randomized participants who received at least one application of study product. Only those participants with data available at the indicated time points were analyzed

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed	169	176
Least Squares Mean (Standard Error); Unit of Measure: Percent change in lesions
	-42.16 (1.890)	-35.33 (1.850)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	The analysis method was mixed model repeated measures analysis with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-6.83
	Confidence Interval	(2-Sided) 95%; -11.88 to -1.78
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

2. Secondary Outcome

Title	Percent Change From Baseline in TLs to Weeks 1, 4, 8 and 12
Description	The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.
Time Frame	Baseline (Day 1) and Week 1, 4, 8, 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed		172	177
Least Squares Mean (Standard Error); Unit of Measure: Percent change in lesions
Week 1	Number Analyzed	172 participants	176 participants
		-24.58 (1.729)	-24.33 (1.697)
Week 4	Number Analyzed	169 participants	174 participants
		-55.51 (1.670)	-49.65 (1.637)
Week 8	Number Analyzed	167 participants	172 participants
		-65.23 (1.544)	-62.88 (1.514)
Week 12	Number Analyzed	164 participants	169 participants
		-74.60 (1.314)	-71.36 (1.288)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.916
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-0.25
	Confidence Interval	(2-Sided) 95%; -4.85 to 4.35
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.010
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-5.85
	Confidence Interval	(2-Sided) 95%; -10.29 to -1.42
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.257
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-2.35
	Confidence Interval	(2-Sided) 95%; -6.42 to 1.72
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.062
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-3.24
	Confidence Interval	(2-Sided) 95%; -6.64 to 0.16
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12

3. Secondary Outcome

Title	Percent Change Form Baseline in Lesion Counts (ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Description	The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones). Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. Percent change from Baseline is the change from Baseline divided by Baseline value multiplied by 100. The Baseline value was the latest pre-dose assessment value. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator).
Time Frame	Baseline (Day 1) and Week 1, 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed		172	177
Least Squares Mean (Standard Error); Unit of Measure: Percent change in lesions
Week 1 ILs	Number Analyzed	172 participants	176 participants
		-42.97 (2.349)	-37.89 (2.309)
Week 2 ILs	Number Analyzed	169 participants	176 participants
		-60.92 (2.209)	-52.49 (2.162)
Week 4 ILs	Number Analyzed	169 participants	174 participants
		-70.68 (1.898)	-61.30 (1.860)
Week 8 ILs	Number Analyzed	167 participants	172 participants
		-76.33 (1.717)	-69.64 (1.682)
Week 12 ILs	Number Analyzed	164 participants	169 participants
		-82.07 (1.403)	-77.58 (1.374)
Week 1 non-ILs	Number Analyzed	172 participants	176 participants
		-15.13 (2.279)	-17.85 (2.239)
Week 2 non-ILs	Number Analyzed	169 participants	176 participants
		-32.71 (2.419)	-27.01 (2.367)
Week 4 non-ILs	Number Analyzed	169 participants	174 participants
		-47.64 (2.171)	-43.74 (2.129)
Week 8 non-ILs	Number Analyzed	167 participants	172 participants
		-59.50 (1.910)	-58.91 (1.872)
Week 12 non-ILs	Number Analyzed	164 participants	169 participants
		-71.07 (1.603)	-67.29 (1.571)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.115
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-5.08
	Confidence Interval	(2-Sided) 95%; -11.41 to 1.25
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-8.43
	Confidence Interval	(2-Sided) 95%; -14.35 to -2.51
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-9.37
	Confidence Interval	(2-Sided) 95%; -14.42 to -4.33
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.004
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-6.69
	Confidence Interval	(2-Sided) 95%; -11.21 to -2.16
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.015
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.50
	Confidence Interval	(2-Sided) 95%; -8.10 to -0.89
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.382
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	2.71
	Confidence Interval	(2-Sided) 95%; -3.38 to 8.80
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.085
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-5.69
	Confidence Interval	(2-Sided) 95%; -12.17 to 0.78
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.186
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-3.89
	Confidence Interval	(2-Sided) 95%; -9.67 to 1.88
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.818
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-0.59
	Confidence Interval	(2-Sided) 95%; -5.61 to 4.44
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.073
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	difference in percent
	Estimated Value	-3.78
	Confidence Interval	(2-Sided) 95%; -7.92 to 0.35
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

4. Secondary Outcome

Title	Absolute Change From Baseline in Lesion Counts (TLs, ILs and Non-ILs) to Weeks 1, 2, 4, 8 and 12
Description	The assessor performed a count of IL (papules, pustules, nodular lesions), non-ILs (open and closed comedones) and total lesions (the sum of IL and non-IL) at each study visit. Lesion counts were confined to the face. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Data for adjusted mean has been reported. The non-ILs were counted by diagnosis based on palpation of the investigator (or sub-investigator). A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM. The Baseline value was the latest pre-dose assessment value.
Time Frame	Baseline (Day 1) and Week 1, 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed		172	177
Least Squares Mean (Standard Error); Unit of Measure: lesion count
Week 1 TLs	Number Analyzed	172 participants	176 participants
		-24.4 (1.70)	-24.3 (1.67)
Week 2 TLs	Number Analyzed	169 participants	176 participants
		-41.8 (1.88)	-35.6 (1.84)
Week 4 TLs	Number Analyzed	169 participants	174 participants
		-56.3 (1.71)	-51.6 (1.67)
Week 8 TLs	Number Analyzed	167 participants	172 participants
		-66.4 (1.60)	-65.7 (1.57)
Week 12 TLs	Number Analyzed	164 participants	169 participants
		-76.2 (1.37)	-74.5 (1.34)
Week 1 ILs	Number Analyzed	172 participants	176 participants
		-13.3 (0.74)	-11.5 (0.72)
Week 2 ILs	Number Analyzed	169 participants	176 participants
		-19.3 (0.70)	-16.3 (0.68)
Week 4 ILs	Number Analyzed	169 participants	174 participants
		-22.4 (0.62)	-19.8 (0.60)
Week 8 ILs	Number Analyzed	167 participants	172 participants
		-24.3 (0.56)	-22.4 (0.55)
Week 12 ILs	Number Analyzed	164 participants	169 participants
		-26.0 (0.48)	-24.9 (0.47)
Week 1 non-ILs	Number Analyzed	172 participants	176 participants
		-11.1 (1.46)	-12.9 (1.43)
Week 2 non-ILs	Number Analyzed	169 participants	176 participants
		-22.5 (1.59)	-19.3 (1.56)
Week 4 non-ILs	Number Analyzed	169 participants	174 participants
		-34.0 (1.46)	-32.0 (1.44)
Week 8 non-ILs	Number Analyzed	167 participants	172 participants
		-42.2 (1.33)	-43.4 (1.31)
Week 12 non-ILs	Number Analyzed	164 participants	169 participants
		-50.2 (1.11)	-49.6 (1.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.961
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.1
	Confidence Interval	(2-Sided) 95%; -4.6 to 4.4
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.015
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.2
	Confidence Interval	(2-Sided) 95%; -11.2 to -1.2
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.044
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.7
	Confidence Interval	(2-Sided) 95%; -9.2 to -0.1
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.747
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.7
	Confidence Interval	(2-Sided) 95%; -4.9 to 3.5
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.338
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline TLs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.7
	Confidence Interval	(2-Sided) 95%; -5.3 to 1.8
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.068
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95%; -3.8 to 0.1
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.8 to -1.1
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -4.3 to -1.0
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.012
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.9
	Confidence Interval	(2-Sided) 95%; -3.4 to -0.4
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.078
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.1
	Confidence Interval	(2-Sided) 95%; -2.4 to 0.1
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.367
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -2.1 to 5.7
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.148
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.1
	Confidence Interval	(2-Sided) 95%; -7.4 to 1.1
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.314
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -5.9 to 1.9
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.494
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	1.2
	Confidence Interval	(2-Sided) 95%; -2.3 to 4.7
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.684
	Comments	The analysis method was mixed-model for repeated measures with treatment, center, visit, treatment-by-visit interaction, Baseline non-ILs counts, Baseline-by-visit interaction as fixed effects.
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.6
	Confidence Interval	(2-Sided) 95%; -3.5 to 2.3
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

5. Secondary Outcome

Title	Percentage of Participants With a Minimum of 2-grade Improvement in Investigator's Static Global Assessment (ISGA) Score From Baseline to Weeks 1, 2, 4, 8 and 12
Description	Responder was defined as participants with a minimum 2-grade improvement in ISGA score from Baseline. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 2-grade improvement in ISGA score from Baseline by total number of participants value multiplied by 100.
Time Frame	Week 1, 2, 4, 8, 12

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed	172	177
Measure Type: Number; Unit of Measure: Percentage of participants
Week 1	2	0
Week 2	6	3
Week 4	12	8
Week 8	22	12
Week 12	37	27

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.047
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 0.1 to 4.6
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1.The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.185
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.0
	Confidence Interval	(2-Sided) 95%; -1.3 to 7.3
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.251
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.7
	Confidence Interval	(2-Sided) 95%; -2.5 to 9.9
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	10.2
	Confidence Interval	(2-Sided) 95%; 2.4 to 18.0
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.022
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	10.7
	Confidence Interval	(2-Sided) 95%; 0.9 to 20.4
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

6. Secondary Outcome

Title	Percentage of Participants With ISGA Score of 0 or 1 at Weeks 1, 2, 4, 8 and 12
Description	Responder was defined as participant with ISGA score of 0 or 1. ISGA scale was scored from 0-5 (0= Clear skin with no inflammatory or non-ILs, 1= Almost clear: rare non-ILs present, with no more than rare papules, 2= Mild severity: greater than Grade 1, some non-ILs with no more than few inflammatory lesions, 3= Moderate severity: greater than Grade 2, many non-ILS, may have some ILs, but no more than 1 small nodular lesion, 4= Severe: greater than Grade 3, up to many non-ILs and ILs, but no more than a few nodular lesions, 5= Very severe: many non -ILs and ILs and more than a few nodular lesions. May have cystic lesions). Percentage of participants was calculated by dividing number of participants with 0-1 ISGA score post Baseline by total number of participants value multiplied by 100.
Time Frame	Week 1, 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed	172	177
Measure Type: Number; Unit of Measure: Percentage of participants
Week 1	2	1
Week 2	6	5
Week 4	13	6
Week 8	20	12
Week 12	41	29

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.129
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	1.8
	Confidence Interval	(2-Sided) 95%; -0.7 to 4.3
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.612
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	1.3
	Confidence Interval	(2-Sided) 95%; -3.4 to 5.9
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.016
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	7.1
	Confidence Interval	(2-Sided) 95%; 1.1 to 13.2
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.034
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	7.9
	Confidence Interval	(2-Sided) 95%; 0.3 to 15.5
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.018
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	11.3
	Confidence Interval	(2-Sided) 95%; 1.4 to 21.3
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

7. Secondary Outcome

Title	Percentage of Participants With at Least 50% Reduction in Lesion Counts (TLs, ILs and Non-ILs) From Baseline at Weeks 1, 2, 4, 8 and 12
Description	Responder was defined as participants with at least a 50% reduction in TLs, ILs and non-ILs. Data for number of participants is reported. Percentage of participants was calculated by dividing number of responders by total number of participants value multiplied by 100.
Time Frame	Week 1, 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed		172	177
Measure Type: Number; Unit of Measure: Percentage of participants
Week 1 TLs	Number Analyzed	172 participants	176 participants
		22	18
Week 2 TLs	Number Analyzed	172 participants	177 participants
		47	42
Week 4 TLs	Number Analyzed	172 participants	177 participants
		67	60
Week 8 TLs	Number Analyzed	172 participants	177 participants
		81	81
Week 12 TLs	Number Analyzed	172 participants	177 participants
		88	86
Week 1 ILs	Number Analyzed	172 participants	176 participants
		51	42
Week 2 ILs	Number Analyzed	172 participants	177 participants
		77	66
Week 4 ILs	Number Analyzed	172 participants	177 participants
		85	76
Week 8 ILs	Number Analyzed	172 participants	177 participants
		87	84
Week 12 ILs	Number Analyzed	172 participants	177 participants
		92	89
Week 1 non-ILs	Number Analyzed	172 participants	176 participants
		14	16
Week 2 non-ILs	Number Analyzed	172 participants	177 participants
		37	34
Week 4 non-ILs	Number Analyzed	172 participants	177 participants
		58	54
Week 8 non-ILs	Number Analyzed	172 participants	177 participants
		73	73
Week 12 non-ILs	Number Analyzed	172 participants	177 participants
		83	80

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.379
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; -4.5 to 12.3
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.409
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	4.7
	Confidence Interval	(2-Sided) 95%; -5.7 to 15.1
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.180
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	7.0
	Confidence Interval	(2-Sided) 95%; -3.1 to 17.0
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.810
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.5
	Confidence Interval	(2-Sided) 95%; -8.8 to 7.7
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.648
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	1.9
	Confidence Interval	(2-Sided) 95%; -5.2 to 9.0
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for TLs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.048
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	9.1
	Confidence Interval	(2-Sided) 95%; -1.3 to 19.6
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.016
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	11.2
	Confidence Interval	(2-Sided) 95%; 1.8 to 20.6
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.044
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	8.6
	Confidence Interval	(2-Sided) 95%; 0.4 to 16.9
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.345
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; -3.8 to 11.0
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.424
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	2.6
	Confidence Interval	(2-Sided) 95%; -3.5 to 8.7
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.527
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -9.4 to 5.5
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 1 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.584
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.3
	Confidence Interval	(2-Sided) 95%; -6.7 to 13.4
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.519
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; -6.5 to 14.3
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.766
	Comments	The P-values are based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.8
	Confidence Interval	(2-Sided) 95%; -10.1 to 8.5
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.666
	Comments	The P-value was based on the Cochran-Mantel-Haenszel test stratified by center.
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; -5.8 to 10.5
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12 for non-ILs. The participants with missing data at a visit were included in the denominator (n) at the visit. That is, those participants were treated as non-responder at the visit.

8. Secondary Outcome

Title	Number of Participants With Treatment Adherence Rate at Weeks 1, 2, 4, 8 and 12
Description	The investigator (or sub-investigator), the product storage manager, or the blinded coordinator dispensed a study compliance log to record participant's compliance with investigational product application from Baseline to the end of study treatment. The product storage manager or the blinded coordinator evaluated the participant's compliance with study treatment, using the study compliance log at each visit, and recorded the compliance data in the eCRF.
Time Frame	Week 1, 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Overall Number of Participants Analyzed	172	177
Measure Type: Number; Unit of Measure: Participants
week 1	143	131
week 2	125	115
week 4	110	85
week 8	89	72
week 12	88	63

9. Secondary Outcome

Title	Number of Participants Who Continued Treatment at Weeks 1, 2, 4, 8 and 12
Description	Number of participants who continued the treatment till Week 12 was measured. Overall data for participants who have not missed any dose during the treatment period has been reported.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Overall Number of Participants Analyzed	172	177
Measure Type: Number; Unit of Measure: Participants
	63	59

10. Secondary Outcome

Title	Participant's Treatment Preference at Weeks 1, 2, 4, 8 and 12
Description	Participants had to rate each question on a 5-point scale of 0 to 4 (4: yes, very easy to use, 3: yes, easy, 2: slightly easy, 1: slightly difficult, 0: No) where larger score indicates more preferable participant's feeling. There were 5 questions in the questionnaire: ease of application, comfort, satisfaction with treatment (ST), comparison with prior therapies (CPT) and willingness to continue using the product (WCP).
Time Frame	Week 1, 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed		172	177
Measure Type: Count of Participants; Unit of Measure: Participants
Week 1: Ease of application, Score 4	Number Analyzed	172 participants	176 participants
		131 76.2%	95 54.0%
Week 1: Ease of application, Score 3	Number Analyzed	172 participants	176 participants
		38 22.1%	66 37.5%
Week 1: Ease of application, Score 2	Number Analyzed	172 participants	176 participants
		2 1.2%	13 7.4%
Week 1: Ease of application, Score 1	Number Analyzed	172 participants	176 participants
		1 0.6%	2 1.1%
Week 2: Ease of application, Score 4	Number Analyzed	169 participants	176 participants
		128 75.7%	83 47.2%
Week 2: Ease of application, Score 3	Number Analyzed	169 participants	176 participants
		38 22.5%	75 42.6%
Week 2: Ease of application, Score 2	Number Analyzed	169 participants	176 participants
		2 1.2%	17 9.7%
Week 2: Ease of application, Score 1	Number Analyzed	169 participants	176 participants
		1 0.6%	1 0.6%
Week 4: Ease of application, Score 4	Number Analyzed	169 participants	174 participants
		118 69.8%	85 48.9%
Week 4: Ease of application, Score 3	Number Analyzed	169 participants	174 participants
		49 29.0%	70 40.2%
Week 4: Ease of application, Score 2	Number Analyzed	169 participants	174 participants
		2 1.2%	18 10.3%
Week 4: Ease of application, Score 1	Number Analyzed	169 participants	174 participants
		0 0.0%	1 0.6%
Week 8: Ease of application, Score 4	Number Analyzed	167 participants	172 participants
		114 68.3%	90 52.3%
Week 8: Ease of application, Score 3	Number Analyzed	167 participants	172 participants
		50 29.9%	60 34.9%
Week 8: Ease of application, Score 2	Number Analyzed	167 participants	172 participants
		3 1.8%	19 11.0%
Week 8: Ease of application, Score 1	Number Analyzed	167 participants	172 participants
		0 0.0%	3 1.7%
Week 12: Ease of application, Score 4	Number Analyzed	164 participants	169 participants
		116 70.7%	81 47.9%
Week 12: Ease of application, Score 3	Number Analyzed	164 participants	169 participants
		44 26.8%	68 40.2%
Week 12: Ease of application, Score 2	Number Analyzed	164 participants	169 participants
		4 2.4%	18 10.7%
Week 12: Ease of application, Score 1	Number Analyzed	164 participants	169 participants
		0 0.0%	2 1.2%
Week 1: Comfort, Score 4	Number Analyzed	172 participants	176 participants
		37 21.5%	24 13.6%
Week 1: Comfort, Score 3	Number Analyzed	172 participants	176 participants
		86 50.0%	69 39.2%
Week 1: Comfort, Score 2	Number Analyzed	172 participants	176 participants
		37 21.5%	45 25.6%
Week 1: Comfort, Score 1	Number Analyzed	172 participants	176 participants
		7 4.1%	32 18.2%
Week 1: Comfort, Score 0	Number Analyzed	172 participants	176 participants
		5 2.9%	6 3.4%
Week 2: Comfort, Score 4	Number Analyzed	169 participants	176 participants
		56 33.1%	35 19.9%
Week 2: Comfort, Score 3	Number Analyzed	169 participants	176 participants
		70 41.4%	81 46.0%
Week 2: Comfort, Score 2	Number Analyzed	169 participants	176 participants
		36 21.3%	42 23.9%
Week 2: Comfort, Score 1	Number Analyzed	169 participants	176 participants
		6 3.6%	17 9.7%
Week 2: Comfort, Score 0	Number Analyzed	169 participants	176 participants
		1 0.6%	1 0.6%
Week 4: Comfort, Score 4	Number Analyzed	169 participants	174 participants
		72 42.6%	47 27.0%
Week 4: Comfort, Score 3	Number Analyzed	169 participants	174 participants
		75 44.4%	80 46.0%
Week 4: Comfort, Score 2	Number Analyzed	169 participants	174 participants
		17 10.1%	31 17.8%
Week 4: Comfort, Score 1	Number Analyzed	169 participants	174 participants
		5 3.0%	15 8.6%
Week 4: Comfort, Score 0	Number Analyzed	169 participants	174 participants
		0 0.0%	1 0.6%
Week 8: Comfort, Score 4	Number Analyzed	167 participants	172 participants
		79 47.3%	53 30.8%
Week 8: Comfort, Score 3	Number Analyzed	167 participants	172 participants
		69 41.3%	68 39.5%
Week 8: Comfort, Score 2	Number Analyzed	167 participants	172 participants
		18 10.8%	36 20.9%
Week 8: Comfort, Score 1	Number Analyzed	167 participants	172 participants
		1 0.6%	13 7.6%
Week 8: Comfort, Score 0	Number Analyzed	167 participants	172 participants
		0 0.0%	2 1.2%
Week 12: Comfort, Score 4	Number Analyzed	164 participants	169 participants
		84 51.2%	56 33.1%
Week 12: Comfort, Score 3	Number Analyzed	164 participants	169 participants
		66 40.2%	73 43.2%
Week 12: Comfort, Score 2	Number Analyzed	164 participants	169 participants
		13 7.9%	26 15.4%
Week 12: Comfort, Score 1	Number Analyzed	164 participants	169 participants
		1 0.6%	13 7.7%
Week 12: Comfort, Score 0	Number Analyzed	164 participants	169 participants
		0 0.0%	1 0.6%
Week 1: ST, Score 4	Number Analyzed	172 participants	176 participants
		36 20.9%	21 11.9%
Week 1: ST, Score 3	Number Analyzed	172 participants	176 participants
		79 45.9%	75 42.6%
Week 1: ST, Score 2	Number Analyzed	172 participants	176 participants
		46 26.7%	49 27.8%
Week 1: ST, Score 1	Number Analyzed	172 participants	176 participants
		11 6.4%	23 13.1%
Week 1: ST, Score 0	Number Analyzed	172 participants	176 participants
		0 0.0%	8 4.5%
Week 2: ST, Score 4	Number Analyzed	169 participants	176 participants
		58 34.3%	38 21.6%
Week 2: ST, Score 3	Number Analyzed	169 participants	176 participants
		70 41.4%	81 46.0%
Week 2: ST, Score 2	Number Analyzed	169 participants	176 participants
		37 21.9%	47 26.7%
Week 2: ST, Score 1	Number Analyzed	169 participants	176 participants
		4 2.4%	7 4.0%
Week 2: ST, Score 0	Number Analyzed	169 participants	176 participants
		0 0.0%	3 1.7%
Week 4: ST, Score 4	Number Analyzed	169 participants	174 participants
		66 39.1%	44 25.3%
Week 4: ST, Score 3	Number Analyzed	169 participants	174 participants
		72 42.6%	81 46.6%
Week 4: ST, Score 2	Number Analyzed	169 participants	174 participants
		27 16.0%	40 23.0%
Week 4: ST, Score 1	Number Analyzed	169 participants	174 participants
		4 2.4%	8 4.6%
Week 4: ST, Score 0	Number Analyzed	169 participants	174 participants
		0 0.0%	1 0.6%
Week 8: ST, Score 4	Number Analyzed	167 participants	172 participants
		78 46.7%	58 33.7%
Week 8: ST, Score 3	Number Analyzed	167 participants	172 participants
		67 40.1%	72 41.9%
Week 8: ST, Score 2	Number Analyzed	167 participants	172 participants
		17 10.2%	33 19.2%
Week 8: ST, Score 1	Number Analyzed	167 participants	172 participants
		5 3.0%	6 3.5%
Week 8: ST, Score 0	Number Analyzed	167 participants	172 participants
		0 0.0%	3 1.7%
Week 12: ST, Score 4	Number Analyzed	164 participants	169 participants
		82 50.0%	63 37.3%
Week 12: ST, Score 3	Number Analyzed	164 participants	169 participants
		61 37.2%	70 41.4%
Week 12: ST, Score 2	Number Analyzed	164 participants	169 participants
		20 12.2%	29 17.2%
Week 12: ST, Score 1	Number Analyzed	164 participants	169 participants
		1 0.6%	6 3.6%
Week 12: ST, Score 0	Number Analyzed	164 participants	169 participants
		0 0.0%	1 0.6%
Week 1: CPT, Score 4	Number Analyzed	172 participants	176 participants
		77 44.8%	53 30.1%
Week 1: CPT, Score 3	Number Analyzed	172 participants	176 participants
		50 29.1%	45 25.6%
Week 1: CPT, Score 2	Number Analyzed	172 participants	176 participants
		38 22.1%	61 34.7%
Week 1: CPT, Score 1	Number Analyzed	172 participants	176 participants
		7 4.1%	11 6.3%
Week 1: CPT, Score 0	Number Analyzed	172 participants	176 participants
		0 0.0%	6 3.4%
Week 2: CPT, Score 4,	Number Analyzed	169 participants	176 participants
		90 53.3%	57 32.4%
Week 2: CPT, Score 3	Number Analyzed	169 participants	176 participants
		51 30.2%	55 31.3%
Week 2: CPT, Score 2	Number Analyzed	169 participants	176 participants
		25 14.8%	54 30.7%
Week 2: CPT, Score 1	Number Analyzed	169 participants	176 participants
		2 1.2%	10 5.7%
Week 2: CPT, Score 0	Number Analyzed	169 participants	176 participants
		1 0.6%	0 0.0%
Week 4: CPT, Score 4	Number Analyzed	169 participants	174 participants
		100 59.2%	67 38.5%
Week 4: CPT, Score 3	Number Analyzed	169 participants	174 participants
		47 27.8%	52 29.9%
Week 4: CPT, Score 2	Number Analyzed	169 participants	174 participants
		18 10.7%	46 26.4%
Week 4: CPT, Score 1	Number Analyzed	169 participants	174 participants
		4 2.4%	8 4.6%
Week 4: CPT, Score 0	Number Analyzed	169 participants	174 participants
		0 0.0%	1 0.6%
Week 8: CPT, Score 4	Number Analyzed	167 participants	172 participants
		109 65.3%	73 42.4%
Week 8: CPT, Score 3	Number Analyzed	167 participants	172 participants
		38 22.8%	50 29.1%
Week 8: CPT, Score 2	Number Analyzed	167 participants	172 participants
		19 11.4%	40 23.3%
Week 8: CPT, Score 1	Number Analyzed	167 participants	172 participants
		1 0.6%	8 4.7%
Week 8: CPT, Score 0	Number Analyzed	167 participants	172 participants
		0 0.0%	1 0.6%
Week 12: CPT, Score 4	Number Analyzed	164 participants	169 participants
		112 68.3%	78 46.2%
Week 12: CPT, Score 3	Number Analyzed	164 participants	169 participants
		42 25.6%	47 27.8%
Week 12: CPT, Score 2	Number Analyzed	164 participants	169 participants
		8 4.9%	35 20.7%
Week 12: CPT, Score 1	Number Analyzed	164 participants	169 participants
		2 1.2%	7 4.1%
Week 12: CPT, Score 0	Number Analyzed	164 participants	169 participants
		0 0.0%	2 1.2%
Week 1: WCP, Score 4	Number Analyzed	172 participants	176 participants
		64 37.2%	36 20.5%
Week 1: WCP, Score 3	Number Analyzed	172 participants	176 participants
		79 45.9%	78 44.3%
Week 1: WCP, Score 2	Number Analyzed	172 participants	176 participants
		25 14.5%	39 22.2%
Week 1: WCP, Score 1	Number Analyzed	172 participants	176 participants
		4 2.3%	19 10.8%
Week 1: WCP, Score 0	Number Analyzed	172 participants	176 participants
		0 0.0%	4 2.3%
Week 2: WCP, Score 4	Number Analyzed	169 participants	176 participants
		75 44.4%	55 31.3%
Week 2: WCP, Score 3	Number Analyzed	169 participants	176 participants
		72 42.6%	70 39.8%
Week 2: WCP, Score 2	Number Analyzed	169 participants	176 participants
		19 11.2%	38 21.6%
Week 2: WCP, Score 1	Number Analyzed	169 participants	176 participants
		3 1.8%	13 7.4%
Week 4: WCP, Score 4	Number Analyzed	169 participants	174 participants
		88 52.1%	63 36.2%
Week 4: WCP, Score 3	Number Analyzed	169 participants	174 participants
		63 37.3%	75 43.1%
Week 4: WCP, Score 2	Number Analyzed	169 participants	174 participants
		15 8.9%	26 14.9%
Week 4: WCP, Score 1	Number Analyzed	169 participants	174 participants
		3 1.8%	10 5.7%
Week 8: WCP, Score 4	Number Analyzed	167 participants	172 participants
		90 53.9%	62 36.0%
Week 8: WCP, Score 3	Number Analyzed	167 participants	172 participants
		59 35.3%	74 43.0%
Week 8: WCP, Score 2	Number Analyzed	167 participants	172 participants
		15 9.0%	27 15.7%
Week 8: WCP, Score 1	Number Analyzed	167 participants	172 participants
		3 1.8%	9 5.2%
Week 12: WCP, Score 4	Number Analyzed	164 participants	169 participants
		94 57.3%	70 41.4%
Week 12: WCP, Score 3	Number Analyzed	164 participants	169 participants
		56 34.1%	65 38.5%
Week 12: WCP, Score 2	Number Analyzed	164 participants	169 participants
		12 7.3%	23 13.6%
Week 12: WCP, Score 1	Number Analyzed	164 participants	169 participants
		1 0.6%	11 6.5%
Week 12: WCP, Score 0	Number Analyzed	164 participants	169 participants
		1 0.6%	0 0.0%

11. Secondary Outcome

Title	Change From Baseline in Quality of Life (QoL) Score at Week 2, 4, 8 and 12
Description	QOL questionnaire was assessed using Skindex-16 with 16 questions in 3 multi-item scales: symptoms, emotions and functioning for the past week: skin condition-itching, burning or stinging, hurting, being irritated, persistence/reoccurrence of skin condition, worry about condition, appearance of skin, frustration about skin, embarrassment about skin, being annoyed about your skin, feeling depressed about skin, effects of your skin on your interactions with others, effects of your skin condition on your desire to be with people, skin condition making it hard to show affection, effects of your skin condition on your daily activities and skin condition making it hard to work or do what you enjoy. Data for adjusted mean has been reported. The Baseline value was the latest pre-dose assessment value. Change from Baseline was calculated as the value at endpoint minus the value at Baseline. Scores range from 0-never bothered to 100-always bothered.
Time Frame	Baseline(Day 1) and Week 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed		172	177
Least Squares Mean (Standard Error); Unit of Measure: Score on scale
Week 2	Number Analyzed	169 participants	176 participants
		-0.71 (0.070)	-0.49 (0.068)
Week 4	Number Analyzed	169 participants	174 participants
		-1.02 (0.069)	-0.80 (0.068)
Week 8	Number Analyzed	167 participants	172 participants
		-1.14 (0.073)	-0.92 (0.071)
Week 12	Number Analyzed	164 participants	169 participants
		-1.27 (0.073)	-1.10 (0.072)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.017
	Comments	[Not Specified]
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.40 to -0.04
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 2. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.017
	Comments	[Not Specified]
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.40 to -0.04
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 4. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.024
	Comments	[Not Specified]
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.22
	Confidence Interval	(2-Sided) 95%; -0.41 to -0.03
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 8. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	DUAC, ADA 0.1% +CLDM 1%
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.080
	Comments	[Not Specified]
	Method	mixed model repeated measures analysis
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 95%; -0.36 to 0.02
	Estimation Comments	Comparison between DUAC and ADA 0.1% +CLDM 1% at Week 12. A negative treatment difference indicates a benefit of Duac relative to ADA+CLDM.

12. Secondary Outcome

Title	Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Medical or scientific judgment was exercised in deciding whether reporting was appropriate. For liver injury and impaired liver function, alanine aminotransferase greater than or equal to (>=)3 times upper limit of normal (ULN) and total bilirubin >=2xULN (less than [>] 35% direct) was defined.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
Overall Number of Participants Analyzed	172	177
Measure Type: Count of Participants; Unit of Measure: Participants
Any AE	53 30.8%	100 56.5%
Any SAE	1 0.6%	0 0.0%

13. Secondary Outcome

Title	Local Tolerability Score for Erythema, Dryness, Peeling, Itching, and Burning or Stinging
Description	Local tolerability score for erythema (no redness, faint red or pink coloration, barely perceptible, light red or pink coloration, medium red coloration, beet red coloration), dryness (none, barely perceptible dryness with no flakes or fissure formation, easily perceptible dryness with no flakes or fissure formation, easily noted dryness and flakes but no fissure formation, easily noted dryness with flakes and fissure formation), peeling (no peeling, mild localized peeling, mild and diffuse peeling, moderate and diffuse peeling, moderate to prominent, dense peeling) and itching and burning/stinging (normal-no discomfort, noticeable discomfort that causes intermittent awareness, continuous awareness, intermittent awareness and interferes occasionally with normal daily activities, a definite continuous discomfort that interferes with normal daily activities) was assessed on a scale of 0 to 4 (0= absent, 1= slight, 2= mild, 3= moderate and 4= severe).
Time Frame	Week 1, 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title		DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:		Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed		172	177
Mean (Standard Deviation); Unit of Measure: Score on scale
Erythema Week 1	Number Analyzed	170 participants	175 participants
		0.0 (0.61)	0.3 (0.72)
Erythema Week 2	Number Analyzed	169 participants	175 participants
		0.0 (0.68)	0.0 (0.70)
Erythema Week 4	Number Analyzed	169 participants	174 participants
		-0.1 (0.57)	-0.1 (0.64)
Erythema Week 8	Number Analyzed	165 participants	171 participants
		-0.2 (0.68)	-0.2 (0.69)
Erythema Week 12	Number Analyzed	165 participants	168 participants
		-0.2 (0.78)	-0.3 (0.67)
Dryness Week 1	Number Analyzed	170 participants	175 participants
		0.1 (0.54)	0.6 (0.95)
Dryness Week 2	Number Analyzed	169 participants	175 participants
		0.0 (0.50)	0.1 (0.58)
Dryness Week 4	Number Analyzed	169 participants	174 participants
		0.0 (0.52)	0.1 (0.49)
Dryness Week 8	Number Analyzed	165 participants	171 participants
		0.0 (0.58)	0.1 (0.46)
Dryness Week 12	Number Analyzed	165 participants	168 participants
		0.0 (0.45)	0.0 (0.35)
Peeling Week 1	Number Analyzed	170 participants	175 participants
		0.1 (0.43)	0.5 (0.88)
Peeling Week 2	Number Analyzed	169 participants	175 participants
		0.1 (0.33)	0.2 (0.55)
Peeling Week 4	Number Analyzed	169 participants	174 participants
		0.0 (0.34)	0.1 (0.42)
Peeling Week 8	Number Analyzed	165 participants	171 participants
		0.1 (0.39)	0.1 (0.46)
Peeling Week 12	Number Analyzed	165 participants	168 participants
		0.0 (0.31)	0.0 (0.32)
Itching Week 1	Number Analyzed	170 participants	175 participants
		0.0 (0.64)	0.1 (0.81)
Itching Week 2	Number Analyzed	169 participants	175 participants
		0.0 (0.60)	0.1 (0.77)
Itching Week 4	Number Analyzed	169 participants	174 participants
		-0.1 (0.68)	-0.1 (0.62)
Itching Week 8	Number Analyzed	165 participants	171 participants
		-0.2 (0.63)	-0.1 (0.58)
Itching Week 12	Number Analyzed	165 participants	168 participants
		-0.2 (0.66)	-0.2 (0.56)
Burning/Stinging Week 1	Number Analyzed	170 participants	175 participants
		0.0 (0.48)	0.5 (0.85)
Burning/Stinging Week 2	Number Analyzed	169 participants	175 participants
		0.0 (0.44)	0.2 (0.66)
Burning/Stinging Week 4	Number Analyzed	169 participants	174 participants
		0.0 (0.44)	0.0 (0.47)
Burning/Stinging Week 8	Number Analyzed	165 participants	171 participants
		0.0 (0.34)	0.1 (0.53)
Burning/Stinging Week 12	Number Analyzed	165 participants	168 participants
		0.0 (0.39)	0.0 (0.40)

14. Secondary Outcome

Title	Number of Participants With Severity of AEs
Description	The severity of AEs was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
Time Frame	Up to Week 12

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	DUAC	ADA 0.1% +CLDM 1%
Arm/Group Description:	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 g which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.	Participants were instructed to use combination therapy of ADA 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to ILs only.
Overall Number of Participants Analyzed	172	177
Measure Type: Count of Participants; Unit of Measure: Participants
Mild	46 26.7%	91 51.4%
Modertae	6 3.5%	7 4.0%
Severe	1 0.6%	2 1.1%

Adverse Events

Time Frame	AE and SAE were collected up to Week 12.
Adverse Event Reporting Description	For AE and SAE, ITT population was analyzed.
Arm/Group Title	Duac		ADA 0.1% +CLDM 1%
Arm/Group Description	Participants were instructed to use DUAC, a fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity of 2 FTU about 0.6 gram (g) which was sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks.		Participants were instructed to use combination therapy of Adapalene (ADA) 0.1% gel with quantity of 1 FTU about 0.5 g sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and clindamycin (CLDM) 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel was applied subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel was applied to inflammatory lesions (ILs) only.
All-Cause Mortality
	Duac		ADA 0.1% +CLDM 1%
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Duac		ADA 0.1% +CLDM 1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/172 (0.58%)		0/177 (0.00%)
Gastrointestinal disorders
Duodenal ulcer † 1	1/172 (0.58%)		0/177 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Duac		ADA 0.1% +CLDM 1%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	34/172 (19.77%)		78/177 (44.07%)
General disorders
Application site dryness † 1	16/172 (9.30%)	16	44/177 (24.86%)	46
Application site pain † 1	3/172 (1.74%)	3	20/177 (11.30%)	21
Application site erythema † 1	4/172 (2.33%)	4	11/177 (6.21%)	12
Infections and infestations
Nasopharyngitis † 1	12/172 (6.98%)	13	15/177 (8.47%)	16
Skin and subcutaneous tissue disorders
Eczema † 1	2/172 (1.16%)	2	10/177 (5.65%)	11
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: GlaxoSmithKline
• Phone: 866-435-7343

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT02557399
• Other Study ID Numbers: 201884
• First Submitted: June 11, 2015
• First Posted: September 23, 2015
• Results First Submitted: February 24, 2017
• Results First Posted: February 15, 2018
• Last Update Posted: August 20, 2018