Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects

• ClinicalTrials.gov Identifier: NCT01445301
• Recruitment Status: Completed
• First Posted: October 3, 2011
• Results First Posted: April 27, 2018
• Last Update Posted: April 27, 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: GSK2585823(CLDM 1%-BPO 3% gel); Drug: CLDM 1% gel twice daily
• Enrollment: 800

Participant Flow

Recruitment Details	A total of 800 Japanese participants across 26 investigational centers in Japan, with Acne Vulgaris were enrolled in this study. The study was conducted from 27 September 2011 - 02 August 2012.
Pre-assignment Details

Arm/Group Title	GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description	Participants were instructed to apply GSK2585823 (Topical gel in 1 gram (g) containing clindamycin (CLDM) 10 milligram (mg) and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU (Finger Tip Unit).	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Period Title: Overall Study
Started	204	297	299
Completed	183	262	290
Not Completed	21	35	9
Reason Not Completed
Adverse Event	15	25	4
Lack of Efficacy	0	1	0
Protocol Violation	1	0	0
Protocol-Defined Stopping Criteria	0	1	1
Physician Decision	0	2	0
Withdrawal by Subject	5	6	4

Baseline Characteristics

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily	Total
Arm/Group Description		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Total of all reporting groups
Overall Number of Baseline Participants		204	296	299	799
Baseline Analysis Population Description		Intent-to-treat (ITT) population comprised all randomized participants who received at least one application of investigational product. One participant excluded was randomized but was not administered study drug. 799 participant were included in the ITT population.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	204 participants	296 participants	299 participants	799 participants
		20.4 (6.06)	20.7 (6.33)	21.1 (6.55)	20.8 (6.34)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	204 participants	296 participants	299 participants	799 participants
	Female	139 68.1%	187 63.2%	202 67.6%	528 66.1%
	Male	65 31.9%	109 36.8%	97 32.4%	271 33.9%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	204 participants	296 participants	299 participants	799 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	204 100.0%	296 100.0%	299 100.0%	799 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Absolute Change From Baseline to Week 12 in Total Lesion Counts.
Description	The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from post-randomization value at Week 12.
Time Frame	Baseline (Day 1) and Week 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at the indicated time points were analyzed.

Arm/Group Title	GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed	201	289	299
Least Squares Mean (Standard Error); Unit of Measure: lesion count
	-57.2 (1.94)	-60.8 (1.53)	-49.8 (1.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.0
	Confidence Interval	(2-Sided) 95%; -15.0 to -7.0
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.2
	Confidence Interval	(2-Sided) 95%; -12.9 to -3.6
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Absolute Change From Baseline to Weeks 1, 2, 4, and 8 in Total Lesion Counts
Description	The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time Frame	Baseline (Day 1) and Weeks 1, 2, 4, and 8

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Mean (Standard Deviation); Unit of Measure: lesion count
WEEK 1	Number Analyzed	200 participants	287 participants	295 participants
		-22.9 (19.81)	-25.6 (24.91)	-16.9 (24.40)
WEEK 2	Number Analyzed	201 participants	289 participants	299 participants
		-32.9 (29.18)	-37.9 (28.91)	-26.6 (30.00)
WEEK 4	Number Analyzed	201 participants	289 participants	299 participants
		-41.4 (27.41)	-47.3 (31.04)	-34.8 (30.92)
WEEK 8	Number Analyzed	201 participants	289 participants	299 participants
		-49.1 (28.97)	-54.4 (34.65)	-42.7 (33.49)

3. Secondary Outcome

Title	Absolute Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory and Non-inflammatory Lesion Counts
Description	The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.
Time Frame	Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Least Squares Mean (Standard Error); Unit of Measure: Lesion count
Inflammatory lesions,Week 1	Number Analyzed	200 participants	287 participants	295 participants
		-11.5 (0.60)	-11.1 (0.54)	-8.5 (0.50)
Inflammatory lesions,Week 2	Number Analyzed	201 participants	289 participants	299 participants
		-14.8 (0.90)	-16.4 (0.61)	-13.1 (0.76)
Inflammatory lesions,Week 4	Number Analyzed	201 participants	289 participants	299 participants
		-18.3 (0.93)	-19.1 (0.62)	-16.3 (0.78)
Inflammatory lesions,Week 8	Number Analyzed	201 participants	289 participants	299 participants
		-21.0 (0.98)	-21.3 (0.69)	-18.3 (0.82)
Inflammatory lesions,Week 12	Number Analyzed	201 participants	289 participants	299 participants
		-22.9 (0.99)	-23.3 (0.69)	-20.3 (0.83)
Non-Inflammatory lesions,Week 1	Number Analyzed	200 participants	287 participants	295 participants
		-13.1 (1.26)	-15.6 (1.08)	-9.7 (1.06)
Non-Inflammatory lesions,Week 2	Number Analyzed	201 participants	289 participants	299 participants
		-20.3 (1.53)	-22.8 (1.28)	-14.9 (1.29)
Non-Inflammatory lesions,Week 4	Number Analyzed	201 participants	289 participants	299 participants
		-25.2 (1.58)	-28.9 (1.33)	-19.4 (1.32)
Non-Inflammatory lesions,Week 8	Number Analyzed	201 participants	289 participants	299 participants
		-30.4 (1.62)	-33.9 (1.36)	-24.9 (1.36)
Non-Inflammatory lesions,Week 12	Number Analyzed	201 participants	289 participants	299 participants
		-34.3 (1.60)	-37.5 (1.31)	-28.7 (1.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 1
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.0
	Confidence Interval	(2-Sided) 95%; -4.4 to -1.5
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 2
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.113
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.8
	Confidence Interval	(2-Sided) 95%; -4.0 to 0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 4
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.084
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.0
	Confidence Interval	(2-Sided) 95%; -4.2 to 0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 8
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.026
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.7
	Confidence Interval	(2-Sided) 95%; -5.1 to -0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 12
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.030
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -5.0 to -0.3
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 1
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.028
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.4
	Confidence Interval	(2-Sided) 95%; -6.5 to -0.4
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 2
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.004
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.4
	Confidence Interval	(2-Sided) 95%; -9.1 to -1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 4
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	-5.8
	Confidence Interval	(2-Sided) 95%; -9.6 to -1.9
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 8
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.5
	Confidence Interval	(2-Sided) 95%; -9.4 to -1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	WEEK 12
	Type of Statistical Test	Non-Inferiority
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.6
	Confidence Interval	(2-Sided) 95%; -9.5 to -1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -3.9 to -1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.2
	Confidence Interval	(2-Sided) 95%; -4.7 to -1.6
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.5
	Confidence Interval	(2-Sided) 95%; -4.1 to -0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 8
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.003
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.7
	Confidence Interval	(2-Sided) 95%; -4.5 to -0.9
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.8
	Confidence Interval	(2-Sided) 95%; -4.6 to -1.0
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.0
	Confidence Interval	(2-Sided) 95%; -8.8 to -3.2
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.1
	Confidence Interval	(2-Sided) 95%; -11.4 to -4.7
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.7
	Confidence Interval	(2-Sided) 95%; -13.1 to -6.2
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 8
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.6
	Confidence Interval	(2-Sided) 95%; -12.1 to -5.1
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	WEEK 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.2
	Confidence Interval	(2-Sided) 95%; -11.6 to -4.8
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Total, Inflammatory, and Non- Inflammatory Lesion Counts
Description	The investigator (or subinvestigator) counted all inflammatory lesions (papules, pustules, and nodular lesions) and non-inflammatory lesions (open and closed comedones) on the face at each study visit. An open comedone was an open, widely dilated follicle with black-colored sebum, due to melanin and oxidation, and keratinous material that forms a plug, thereby obstructing the pilosebaceous duct. A closed comedone was a closed follicle filled with impacted sebum covered by keratin that has a whitish color. A papule was a small, raised, red, dome-shaped palpable lesion. A pustule was a raised, dome-shaped palpable lesion containing yellow fluid (pus). A nodule might be a raised or deep-seated, dome-shaped palpable lesion of at least 5 millimeters in diameter. Day 1 was Baseline and change from baseline was calculated by subtracting the Baseline value from value at indicated time points.( Weeks 1, 2, 4, 8 and 12)
Time Frame	Baseline (Day 1) and Weeks 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Least Squares Mean (Standard Error); Unit of Measure: Percent change
Total lesions,Week 1	Number Analyzed	200 participants	287 participants	295 participants
		-32.42 (1.478)	-33.29 (1.312)	-24.71 (1.247)
Total lesions,Week 2	Number Analyzed	201 participants	289 participants	299 participants
		-46.87 (1.953)	-49.29 (1.544)	-38.36 (1.644)
Total lesions,Week 4	Number Analyzed	201 participants	289 participants	299 participants
		-57.15 (1.848)	-59.98 (1.454)	-48.26 (1.556)
Total lesions,Week 8	Number Analyzed	201 participants	289 participants	299 participants
		-66.33 (1.935)	-68.49 (1.551)	-57.20 (1.630)
Total lesions,Week 12	Number Analyzed	201 participants	289 participants	299 participants
		-73.85 (1.929)	-75.57 (1.512)	-64.42 (1.625)
Inflammatory lesions, Week 1	Number Analyzed	200 participants	287 participants	295 participants
		-41.87 (1.885)	-39.76 (1.704)	-31.32 (1.590)
Inflammatory lesions, Week 2	Number Analyzed	201 participants	289 participants	299 participants
		-55.64 (2.277)	-58.31 (1.641)	-48.43 (1.917)
Inflammatory lesions, Week 4	Number Analyzed	201 participants	289 participants	299 participants
		-66.51 (2.181)	-66.89 (1.617)	-58.87 (1.837)
Inflammatory lesions, Week 8	Number Analyzed	201 participants	289 participants	299 participants
		-74.86 (2.256)	-74.37 (1.750)	-66.13 (1.899)
Inflammatory lesions, Week 12	Number Analyzed	201 participants	289 participants	299 participants
		-80.84 (2.120)	-81.14 (1.598)	-72.64 (1.785)
Non-Inflammatory lesions, Week 1	Number Analyzed	200 participants	287 participants	295 participants
		-26.49 (1.846)	-29.20 (1.697)	-20.69 (1.558)
Non-Inflammatory lesions, Week 2	Number Analyzed	201 participants	289 participants	299 participants
		-41.26 (2.392)	-43.43 (2.022)	-32.96 (2.014)
Non-Inflammatory lesions, Week 4	Number Analyzed	201 participants	289 participants	299 participants
		-51.12 (2.246)	-55.40 (1.847)	-41.85 (1.891)
Non-Inflammatory lesions, Week 8	Number Analyzed	201 participants	289 participants	299 participants
		-60.59 (2.247)	-64.83 (1.844)	-51.75 (1.892)
Non-Inflammatory lesions, Week 12	Number Analyzed	201 participants	289 participants	299 participants
		-69.01 (2.219)	-71.90 (1.804)	-59.33 (1.869)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 1
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.71
	Confidence Interval	(2-Sided) 95%; -11.30 to -4.12
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 2
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.51
	Confidence Interval	(2-Sided) 95%; -13.24 to -3.77
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 4
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.89
	Confidence Interval	(2-Sided) 95%; -13.37 to -4.41
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 8
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.12
	Confidence Interval	(2-Sided) 95%; -13.82 to -4.43
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 12
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.43
	Confidence Interval	(2-Sided) 95%; -14.11 to -4.75
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 1
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-10.54
	Confidence Interval	(2-Sided) 95%; -15.12 to -5.97
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 2
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established
Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.21
	Confidence Interval	(2-Sided) 95%; -12.73 to -1.69
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 4
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.64
	Confidence Interval	(2-Sided) 95%; -12.93 to -2.35
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 8
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.73
	Confidence Interval	(2-Sided) 95%; -14.20 to -3.26
	Estimation Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 12
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.20
	Confidence Interval	(2-Sided) 95%; -13.34 to -3.06
	Estimation Comments	[Not Specified]

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 1
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	0.011
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.80
	Confidence Interval	(2-Sided) 95%; -10.29 to -1.32
	Estimation Comments	[Not Specified]

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 2
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.30
	Confidence Interval	(2-Sided) 95%; -14.10 to -2.50
	Estimation Comments	[Not Specified]

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 4
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.27
	Confidence Interval	(2-Sided) 95%; -14.72 to -3.83
	Estimation Comments	[Not Specified]

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 8
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.84
	Confidence Interval	(2-Sided) 95%; -14.28 to -3.39
	Estimation Comments	[Not Specified]

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 12
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	If the upper 95% confidence was less than the pre-defined threshold (-Δ [non-inferiority margin, -3.8]) of 3.8, non-inferiority of GSK2585823 once daily to CLDM twice daily would be established.
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.68
	Confidence Interval	(2-Sided) 95%; -15.06 to -4.30
	Estimation Comments	[Not Specified]

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.90
	Confidence Interval	(2-Sided) 95%; -12.32 to -5.48
	Estimation Comments	[Not Specified]

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.17
	Confidence Interval	(2-Sided) 95%; -15.18 to -7.16
	Estimation Comments	[Not Specified]

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.12
	Confidence Interval	(2-Sided) 95%; -15.90 to -8.35
	Estimation Comments	[Not Specified]

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 8
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.33
	Confidence Interval	(2-Sided) 95%; -15.37 to -7.30
	Estimation Comments	[Not Specified]

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Total Lesion Counts, WEEK 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.18
	Confidence Interval	(2-Sided) 95%; -15.11 to -7.25
	Estimation Comments	[Not Specified]

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.32
	Confidence Interval	(2-Sided) 95%; -12.76 to -3.88
	Estimation Comments	[Not Specified]

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.57
	Confidence Interval	(2-Sided) 95%; -13.83 to -5.30
	Estimation Comments	[Not Specified]

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-7.83
	Confidence Interval	(2-Sided) 95%; -12.03 to -3.62
	Estimation Comments	[Not Specified]

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 8
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.08
	Confidence Interval	(2-Sided) 95%; -12.63 to -3.53
	Estimation Comments	[Not Specified]

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Inflammatory Lesion Counts, WEEK 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.56
	Confidence Interval	(2-Sided) 95%; -12.71 to -4.41
	Estimation Comments	[Not Specified]

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.11
	Confidence Interval	(2-Sided) 95%; -13.53 to -4.68
	Estimation Comments	[Not Specified]

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-11.05
	Confidence Interval	(2-Sided) 95%; -16.30 to -5.80
	Estimation Comments	[Not Specified]

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 4
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-14.17
	Confidence Interval	(2-Sided) 95%; -18.97 to -9.37
	Estimation Comments	[Not Specified]

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 8
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-13.04
	Confidence Interval	(2-Sided) 95%; -17.83 to -8.25
	Estimation Comments	[Not Specified]

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Non-Inflammatory Lesion Counts, WEEK 12
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	ANCOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-12.37
	Confidence Interval	(2-Sided) 95%; -17.05 to -7.68
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Percentage of Participants With a Minimum 2-grade Improvement From Baseline to Week 12 in Investigator's Static Global Assessment (ISGA) Score
Description	Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5(very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time Frame	Baseline (Day 1) and Week 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at the indicated time points were analyzed.

Arm/Group Title	GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed	184	262	290
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	30; (23.4 to 37.1)	31; (25.7 to 37.3)	14; (10.6 to 19.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

6. Secondary Outcome

Title	Percentage of Participants With an ISGA Score of 0 (Clear) or 1 (Almost Clear) at Weeks 1, 2, 4, 8, and 12
Description	Proportion of participants with at least a 2-Grade Improvement in ISGA was reported using a 5 point scale which indicates Score 0 (Clear): skin with no inflammatory or non-inflammatory lesions, Score 1 (Almost Clear): rare non-inflammatory lesions with no more than rare papules, Score 2 (Mild): greater than Grade 1, some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions), Score 3 (Moderate): greater than Grade 2, many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion, Score 4 (Severe): greater than Grade 3, many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions and 5 (very severe): many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. The investigator assessed ISGA score at baseline (Week 0/Day 1) and Weeks 1, 2, 4, 8, and 12. The area evaluated ISGA was limited to the face.
Time Frame	Week 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 1	Number Analyzed	200 participants	287 participants	295 participants
		2; (0.5 to 5.0)	2; (0.8 to 4.5)	1; (0.4 to 3.4)
Week 2	Number Analyzed	197 participants	281 participants	297 participants
		7; (3.9 to 11.6)	5; (2.5 to 7.8)	5; (2.9 to 8.2)
Week 4	Number Analyzed	191 participants	269 participants	296 participants
		11; (6.9 to 16.3)	13; (9.2 to 17.6)	7; (4.7 to 11.0)
Week 8	Number Analyzed	186 participants	260 participants	292 participants
		22; (15.8 to 28.1)	20; (15.3 to 25.4)	9; (5.9 to 12.8)
Week 12	Number Analyzed	184 participants	262 participants	290 participants
		30; (23.4 to 37.1)	34; (27.9 to 39.7)	20; (15.2 to 24.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 1
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.470
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.844
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.022
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 twice daily and CLDM twice daily at Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 1
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.572
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.335
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.187
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of ISGA Score of 0 or 1 between GSK2585823 once daily and CLDM twice daily at Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

7. Secondary Outcome

Title	Percentage of Participants Who Have a Reduction of at Least 50 Percent in Total Lesions
Description	The percentage of participants who had reduction in total lesions (inflammatory and non-inflammatory) of at least 50 percent from Baseline at Weeks 1, 2, 4, 8, and 12 was measured.
Time Frame	Baseline (Day 1) and Week 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at the indicated time points were analyzed.

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
Week 1	Number Analyzed	200 participants	287 participants	295 participants
		18; (12.5 to 23.5)	24; (19.5 to 29.8)	15; (11.1 to 19.5)
Week 2	Number Analyzed	201 participants	289 participants	299 participants
		47; (40.2 to 54.4)	51; (44.9 to 56.8)	32; (26.5 to 37.4)
Week 4	Number Analyzed	201 participants	289 participants	299 participants
		63; (55.6 to 69.4)	71; (65.3 to 76.1)	52; (45.7 to 57.3)
Week 8	Number Analyzed	201 participants	289 participants	299 participants
		79; (72.8 to 84.5)	82; (77.1 to 86.3)	69; (63.0 to 73.8)
Week 12	Number Analyzed	201 participants	289 participants	299 participants
		85; (79.4 to 89.7)	89; (84.3 to 92.0)	79; (73.5 to 83.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 twice daily and CLDM twice daily at Week 1
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 twice daily and CLDM twice daily at Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 twice daily and CLDM twice daily at Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 twice daily and CLDM twice daily at Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Twice Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 twice daily and CLDM twice daily at Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 once daily and CLDM twice daily at Week 1
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.480
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 once daily and CLDM twice daily at Week 2
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 once daily and CLDM twice daily at Week 4
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.009
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 once daily and CLDM twice daily at Week 8
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.008
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	GSK2585823 Once Daily, CLDM Twice Daily
	Comments	Comparison of GSK2585823 once daily and CLDM twice daily at Week 12
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.065
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

8. Secondary Outcome

Title	Minimum Inhibitory Concentration (MIC) of Clinical Isolates to Antibiotics CLDM and Nadifloxacin (NDFX)
Description	MIC50 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 50% of isolates from a particular organism). MIC90 = minimum inhibitory concentration (minimum concentration of an agent that inhibits 90% of isolates from a particular organism) for the susceptibility of clinical isolates (Propionibacterium acnes before and after application of the CLDM and NDFX was reported. MIC50 and MIC90 values are single measurements for the entire population and not measured on a per-participant basis.
Time Frame	Baseline (Day 1) and Week12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Measure Type: Number; Unit of Measure: Micrograms/milliliter
CLDM,Baseline,MIC50	Number Analyzed	154 participants	225 participants	220 participants
		0.12	0.12	0.12
CLDM,Baseline,MIC90	Number Analyzed	154 participants	225 participants	220 participants
		1	4	4
CLDM, Week 12,MIC50	Number Analyzed	12 participants	22 participants	59 participants
		0.25	0.5	0.5
CLDM, Week 12,MIC90	Number Analyzed	12 participants	22 participants	59 participants
		128	128	128
NDFX,Baseline,MIC50	Number Analyzed	154 participants	225 participants	220 participants
		0.25	0.25	0.25
NDFX,Baseline,MIC90	Number Analyzed	154 participants	225 participants	220 participants
		0.5	0.5	0.5
NDFX, Week 12,MIC50	Number Analyzed	12 participants	22 participants	59 participants
		0.25	0.25	0.25
NDFX, Week 12,MIC90	Number Analyzed	12 participants	22 participants	59 participants
		0.5	0.5	0.5

9. Secondary Outcome

Title	Change in Investigator Assessment of Tolerability (Erythema, Dryness and Peeling) From Baseline to Weeks 1, 2, 4 and 8 and 12
Description	Erythema (redness), dryness, and peeling, were evaluated independently by the investigator on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time Frame	Baseline (Day 1) and Week 1, 2, 4, 8, and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles).

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Mean (Standard Deviation); Unit of Measure: Score on scale
Erythema score-Week 1	Number Analyzed	198 participants	285 participants	298 participants
		-0.11 (0.58)	-0.00 (0.63)	-0.11 (0.52)
Erythema score-Week 2	Number Analyzed	192 participants	275 participants	297 participants
		-0.16 (0.76)	-0.02 (0.82)	-0.19 (0.58)
Erythema score-Week 4	Number Analyzed	187 participants	266 participants	294 participants
		-0.30 (0.72)	-0.24 (0.75)	-0.27 (0.62)
Erythema score-Week 8	Number Analyzed	185 participants	262 participants	291 participants
		-0.43 (0.82)	-0.33 (0.78)	-0.31 (0.67)
Erythema score-Week 12	Number Analyzed	183 participants	262 participants	290 participants
		-0.49 (0.82)	-0.45 (0.87)	-0.38 (0.75)
Dryness yscore-Week 1	Number Analyzed	198 participants	285 participants	298 participants
		0.10 (0.65)	0.29 (0.76)	-0.04 (0.47)
Dryness score-Week 2	Number Analyzed	192 participants	275 participants	297 participants
		0.04 (0.65)	0.23 (0.80)	-0.11 (0.51)
Dryness score-Week 4	Number Analyzed	187 participants	266 participants	294 participants
		-0.06 (0.57)	0.00 (0.65)	-0.15 (0.53)
Dryness score-Week 8	Number Analyzed	185 participants	262 participants	291 participants
		-0.11 (0.61)	-0.00 (0.67)	-0.13 (0.50)
Dryness score-Week 12	Number Analyzed	183 participants	262 participants	290 participants
		-0.18 (0.62)	-0.10 (0.61)	-0.17 (0.52)
Peeling score-Week 1	Number Analyzed	198 participants	285 participants	298 participants
		0.09 (0.50)	0.19 (0.68)	-0.04 (0.39)
Peeling score-Week 2	Number Analyzed	192 participants	275 participants	297 participants
		0.02 (0.49)	0.17 (0.68)	-0.10 (0.39)
Peeling score-Week 4	Number Analyzed	187 participants	266 participants	294 participants
		-0.05 (0.44)	0.04 (0.54)	-0.14 (0.43)
Peeling score-Week 8	Number Analyzed	185 participants	262 participants	291 participants
		-0.08 (0.46)	0.03 (0.56)	-0.13 (0.43)
Peeling score-Week 12	Number Analyzed	183 participants	262 participants	290 participants
		-0.08 (0.49)	-0.07 (0.51)	-0.13 (0.44)

10. Secondary Outcome

Title	Change in Participant Assessment of Tolerability ( Itching and Burning/Stinging ) From Baseline to Weeks 1, 2, 4, 8 and 12
Description	Burning/stinging, itching were evaluated independently by the participant on a five point scale from 0 to 4 defined as 0-none, 1-very minimal, 2-mild, 3-moderate, 4-severe. Day 1 was Baseline and Change from Baseline was calculated by subtracting Baseline value from value at specified time points (Week 1, 2, 4, 8, and 12).
Time Frame	Baseline (Day 1) and Week 1, 2, 4, 8 and 12

Outcome Measure Data

Analysis Population Description

ITT population. Only those participants available at the specified time points were analyzed (represented by n=X. X, X in the category titles).

Arm/Group Title		GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description:		Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
Overall Number of Participants Analyzed		204	296	299
Mean (Standard Deviation); Unit of Measure: Score on scale
Itching Score, Week 1	Number Analyzed	198 participants	285 participants	298 participants
		-0.02 (0.53)	0.07 (0.61)	-0.08 (0.53)
Itching Score, Week 2	Number Analyzed	192 participants	275 participants	297 participants
		-0.06 (0.58)	0.12 (0.73)	-0.13 (0.48)
Itching Score, Week 4	Number Analyzed	187 participants	266 participants	294 participants
		-0.10 (0.51)	-0.02 (0.48)	-0.14 (0.51)
Itching Score, Week 8	Number Analyzed	185 participants	262 participants	291 participants
		-0.15 (0.50)	-0.06 (0.43)	-0.14 (0.55)
Itching Score, Week 12	Number Analyzed	183 participants	262 participants	290 participants
		-0.10 (0.59)	-0.08 (0.53)	-0.12 (0.52)
Burning/Stinging Score, Week 1	Number Analyzed	198 participants	285 participants	298 participants
		0.08 (0.55)	0.26 (0.76)	-0.02 (0.45)
Burning/Stinging Score, Week 2	Number Analyzed	192 participants	275 participants	297 participants
		0.02 (0.45)	0.11 (0.61)	-0.06 (0.37)
Burning/Stinging Score, Week 4	Number Analyzed	187 participants	266 participants	294 participants
		-0.02 (0.43)	-0.02 (0.48)	-0.07 (0.39)
Burning/Stinging Score, Week 8	Number Analyzed	185 participants	262 participants	291 participants
		-0.02 (0.44)	-0.04 (0.47)	-0.08 (0.39)
Burning/Stinging Score, Week 12	Number Analyzed	183 participants	262 participants	290 participants
		-0.06 (0.38)	-0.08 (0.38)	-0.08 (0.37)

Adverse Events

Time Frame	Adverse events were collected from Day 1 throughout the treatment period up to Week 12. There were no serious adverse events in this study. Data has been presented for non serious adverse events up to Week 12.
Adverse Event Reporting Description	ITT population was used.
Arm/Group Title	GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
Arm/Group Description	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) once daily in the evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply GSK2585823 (Topical gel in 1 g containing CLDM 10 mg and benzoyl peroxide 30 mg) a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.	Participants were instructed to apply CLDM (topical gel containing CLDM 10 mg/1 g gel) that is Dalacin® T Gel 1% a quantity sufficient to cover the entire face (including the forehead, nose, cheeks, and chin) twice daily in the morning and evening/bedtime for 12 weeks. The indication of application volume was 2 FTU.
All-Cause Mortality
	GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/204 (0.00%)	0/296 (0.00%)	0/299 (0.00%)
Serious Adverse Events
	GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/204 (0.00%)	0/296 (0.00%)	0/299 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	GSK2585823 Once Daily	GSK2585823 Twice Daily	CLDM Twice Daily
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	108/204 (52.94%)	163/296 (55.07%)	110/299 (36.79%)
Blood and lymphatic system disorders
Leukopenia † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Cardiac disorders
Tachycardia † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Eye disorders
Eyelid oedema † 1	2/204 (0.98%)	2/296 (0.68%)	0/299 (0.00%)
Erythema of eyelid † 1	1/204 (0.49%)	2/296 (0.68%)	0/299 (0.00%)
Blepharitis † 1	1/204 (0.49%)	1/296 (0.34%)	0/299 (0.00%)
Conjunctivitis † 1	0/204 (0.00%)	1/296 (0.34%)	1/299 (0.33%)
Eyelid irritation † 1	0/204 (0.00%)	2/296 (0.68%)	0/299 (0.00%)
Conjunctivitis allergic † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Eczema eyelids † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Eye inflammation † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Eyelids pruritus † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Gastrointestinal disorders
Diarrhoea † 1	2/204 (0.98%)	1/296 (0.34%)	2/299 (0.67%)
Abdominal pain † 1	0/204 (0.00%)	0/296 (0.00%)	2/299 (0.67%)
Abdominal pain upper † 1	0/204 (0.00%)	0/296 (0.00%)	2/299 (0.67%)
Aphthous stomatitis † 1	0/204 (0.00%)	2/296 (0.68%)	0/299 (0.00%)
Dental caries † 1	1/204 (0.49%)	1/296 (0.34%)	0/299 (0.00%)
Gastritis † 1	0/204 (0.00%)	1/296 (0.34%)	1/299 (0.33%)
Lip dry † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Nausea † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Proctitis † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Radicular cyst † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Stomatitis † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Toothache † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Vomiting † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
General disorders
Facial pain † 1	9/204 (4.41%)	9/296 (3.04%)	4/299 (1.34%)
Pyrexia † 1	2/204 (0.98%)	0/296 (0.00%)	1/299 (0.33%)
Feeling hot † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Nodule † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Immune system disorders
Seasonal allergy † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Infections and infestations
Nasopharyngitis † 1	28/204 (13.73%)	48/296 (16.22%)	39/299 (13.04%)
Influenza † 1	4/204 (1.96%)	9/296 (3.04%)	7/299 (2.34%)
Gastroenteritis † 1	3/204 (1.47%)	2/296 (0.68%)	0/299 (0.00%)
Oral herpes † 1	2/204 (0.98%)	0/296 (0.00%)	1/299 (0.33%)
Pneumonia mycoplasmal † 1	2/204 (0.98%)	0/296 (0.00%)	1/299 (0.33%)
Herpes zoster † 1	0/204 (0.00%)	1/296 (0.34%)	1/299 (0.33%)
Infected dermal cyst † 1	2/204 (0.98%)	0/296 (0.00%)	0/299 (0.00%)
Acute tonsillitis † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Bronchitis † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Enteritis infectious † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Folliculitis † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Hordeolum † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Impetigo † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Pericoronitis † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Rhinitis † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Skin infection † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Tinea pedis † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Upper respiratory tract infection † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Varicella † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Vulvovaginal candidiasis † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Injury, poisoning and procedural complications
Thermal burn † 1	2/204 (0.98%)	2/296 (0.68%)	2/299 (0.67%)
Contusion † 1	1/204 (0.49%)	1/296 (0.34%)	3/299 (1.00%)
Ligament sprain † 1	1/204 (0.49%)	3/296 (1.01%)	0/299 (0.00%)
Arthropod bite † 1	1/204 (0.49%)	0/296 (0.00%)	2/299 (0.67%)
Excoriation † 1	0/204 (0.00%)	0/296 (0.00%)	2/299 (0.67%)
Arthropod sting † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Eye injury † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Fractured coccyx † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Hand fracture † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Laceration † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Muscle strain † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Investigations
Alanine aminotransferase increased † 1	3/204 (1.47%)	0/296 (0.00%)	5/299 (1.67%)
Aspartate aminotransferase increased † 1	3/204 (1.47%)	1/296 (0.34%)	4/299 (1.34%)
Blood bilirubin increased † 1	1/204 (0.49%)	2/296 (0.68%)	5/299 (1.67%)
White blood cell count increased † 1	1/204 (0.49%)	3/296 (1.01%)	1/299 (0.33%)
Gamma-glutamyltransferase increased † 1	0/204 (0.00%)	0/296 (0.00%)	4/299 (1.34%)
Glucose urine present † 1	1/204 (0.49%)	1/296 (0.34%)	2/299 (0.67%)
Protein urine present † 1	2/204 (0.98%)	0/296 (0.00%)	2/299 (0.67%)
Blood alkaline phosphatase increased † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Blood lactate dehydrogenase increased † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
White blood cell count decreased † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Neck pain † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Plantar fasciitis † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma † 1	0/204 (0.00%)	1/296 (0.34%)	2/299 (0.67%)
Nervous system disorders
Burning sensation † 1	6/204 (2.94%)	12/296 (4.05%)	4/299 (1.34%)
Headache † 1	2/204 (0.98%)	3/296 (1.01%)	0/299 (0.00%)
Dizziness postural † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Respiratory, thoracic and mediastinal disorders
Asthma † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Oropharyngeal pain † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Rhinitis allergic † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Upper respiratory tract inflammation † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Skin and subcutaneous tissue disorders
Dry skin † 1	17/204 (8.33%)	35/296 (11.82%)	8/299 (2.68%)
Dermatitis contact † 1	14/204 (6.86%)	24/296 (8.11%)	5/299 (1.67%)
Erythema † 1	8/204 (3.92%)	22/296 (7.43%)	8/299 (2.68%)
Pruritus † 1	9/204 (4.41%)	17/296 (5.74%)	6/299 (2.01%)
Skin exfoliation † 1	4/204 (1.96%)	25/296 (8.45%)	2/299 (0.67%)
Eczema † 1	4/204 (1.96%)	10/296 (3.38%)	7/299 (2.34%)
Dermatitis exfoliative † 1	4/204 (1.96%)	6/296 (2.03%)	4/299 (1.34%)
Skin irritation † 1	3/204 (1.47%)	8/296 (2.70%)	2/299 (0.67%)
Acne † 1	3/204 (1.47%)	4/296 (1.35%)	2/299 (0.67%)
Urticaria † 1	3/204 (1.47%)	3/296 (1.01%)	0/299 (0.00%)
Eczema asteatotic † 1	1/204 (0.49%)	3/296 (1.01%)	1/299 (0.33%)
Dermatitis † 1	1/204 (0.49%)	3/296 (1.01%)	0/299 (0.00%)
Dermatitis atopic † 1	0/204 (0.00%)	0/296 (0.00%)	2/299 (0.67%)
Dyshidrosis † 1	1/204 (0.49%)	1/296 (0.34%)	0/299 (0.00%)
Solar dermatitis † 1	0/204 (0.00%)	1/296 (0.34%)	1/299 (0.33%)
Swelling face † 1	1/204 (0.49%)	1/296 (0.34%)	0/299 (0.00%)
Xeroderma † 1	0/204 (0.00%)	1/296 (0.34%)	1/299 (0.33%)
Asteatosis † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Dandruff † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Eczema nummular † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Hyperkeratosis † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Nail disorder † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
Pityriasis † 1	0/204 (0.00%)	1/296 (0.34%)	0/299 (0.00%)
Rash maculo-papular † 1	0/204 (0.00%)	0/296 (0.00%)	1/299 (0.33%)
Seborrhoeic dermatitis † 1	1/204 (0.49%)	0/296 (0.00%)	0/299 (0.00%)
1 Term from vocabulary, MedDRA 15.0; † Indicates events were collected by systematic assessment

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: NCT01445301
• Other Study ID Numbers: 115287
• First Submitted: September 15, 2011
• First Posted: October 3, 2011
• Results First Submitted: April 11, 2017
• Results First Posted: April 27, 2018
• Last Update Posted: April 27, 2018