Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications

• ClinicalTrials.gov Identifier: NCT00926367
• Recruitment Status: Completed
• First Posted: June 23, 2009
• Results First Posted: August 4, 2011
• Last Update Posted: May 20, 2015
• Sponsor: Stiefel, a GSK Company
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline ( Stiefel, a GSK Company )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Acne Vulgaris
• Interventions: Drug: Clindamycin and benzoyl peroxide; Drug: benzoyl peroxide 2.5% and adapalene 0.1% gel
• Enrollment: 52

Participant Flow

Recruitment Details	Clinical research center.
Pre-assignment Details	Panelists who met the eligibility criteria and were willing to participate in the study were required to undergo a 3-day pre-trial conditioning period where they had to stop the use of all facial products. Panelists were required to use the provided Soap Free Cleanser (SFC) for washing their face and were allowed to apply their normal makeup.

Arm/Group Title	Duac	Epiduo
Arm/Group Description	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Period Title: Overall Study
Started	25	27
Completed	23	24
Not Completed	2	3
Reason Not Completed
Withdrawal by Subject	0	1
Lost to Follow-up	1	0
Skin Irritation	1	2

Baseline Characteristics

Arm/Group Title		Duac	Epiduo	Total
Arm/Group Description		Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene	Total of all reporting groups
Overall Number of Baseline Participants		25	27	52
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	27 participants	52 participants
	<=18 years	1 4.0%	1 3.7%	2 3.8%
	Between 18 and 65 years	24 96.0%	26 96.3%	50 96.2%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	27 participants	52 participants
	Female	23 92.0%	26 96.3%	49 94.2%
	Male	2 8.0%	1 3.7%	3 5.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	25 participants	27 participants	52 participants
		25	27	52

Outcome Measures

1. Primary Outcome

Title	Skin Erythema (Redness)
Description	Assessment of erythema as part of an evaluation of tolerance of two treatments: clindamycin and benzoyl peroxide or dapsone gel. This was done by visual assessment by an independent blinded grader using the grading scale shown below. Grade Description 0 None 2 Mild erythema 4 Moderate confluent erythema 6 Marked erythema with some edema 8 Marked erythema, edema, possible erosion
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: Units on a scale
Baseline	1.56 (0.92)	1.89 (1.01)
Day 1	2.62 (1.32)	2.65 (0.94)
Day 2	2.90 (1.23)	2.52 (1.03)
Day 3	3.08 (1.23)	2.81 (1.02)
Day 6	3.17 (1.33)	3.13 (0.89)
Day 7	3.07 (1.30)	3.08 (1.01)
Day 8	2.87 (1.24)	2.98 (1.08)
Day 9	2.78 (1.36)	3.03 (0.99)
Day 10	2.89 (1.22)	2.94 (1.02)
Day 13	2.85 (1.20)	2.83 (1.21)
Day 14	2.73 (1.20)	2.56 (1.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Duac, Epiduo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	Dunn's Multiple Comparisons Test
	Comments	A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.

2. Primary Outcome

Title	Skin Dryness
Description	The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate skin dryness is: Grade Description 0 None 2 Slight flaking 4 Moderate flaking/scaling 6 Marked scaling / slight fissuring 8 Severe scaling, fissuring Expert Grader assessments of dryness were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.12 (0.44)	0.07 (0.27)
Day 1	0.41 (0.85)	0.25 (0.57)
Day 2	0.32 (0.83)	0.34 (0.59)
Day 3	0.46 (0.91)	0.55 (1.15)
Day 6	0.61 (1.02)	1.73 (1.76)
Day 7	0.69 (1.16)	1.85 (2.01)
Day 8	0.60 (1.13)	1.87 (2.04)
Day 9	0.73 (1.28)	2.29 (1.99)
Day 10	0.56 (1.04)	1.49 (1.77)
Day 13	0.80 (1.33)	1.26 (1.85)
Day 14	0.79 (1.04)	1.33 (1.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Duac, Epiduo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	A two-tailed p≤ 0.05 was taken as the level of significance for all comparisons.
	Method	Dunn's Multiple Comparisons Test
	Comments	[Not Specified]

3. Secondary Outcome

Title	Skin Moisture and Hydration
Description	To assess skin moisture and hydration using transepidermal water loss (TEWL). Results are measured on a continuous scale. Higher values indicate greater water loss/ lower skin moisture levels. Evaporative water loss measurements provide an instrumental assessment of skin barrier function(one of the layers of the skin. Damage leads to a disruption of the barrier that is accompanied by elevated water loss rates and affects skin moisture and hydration. Higher values indicate greater water loss.
Time Frame	Baseline, Days 3, 7, and 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: TEWL rates (gm/m2/hr)
Baseline	11.50 (3.65)	13.07 (5.06)
Day 3	11.38 (2.49)	15.85 (9.12)
Day 7	14.51 (3.65)	21.65 (8.66)
Day 14	13.36 (3.33)	19.28 (8.10)

4. Secondary Outcome

Title	Skin Hydration
Description	The ability of an alternating current to flow through the stratum corneum is an indirect measure of its water content. The value recorded is expressed in microsiemens. Higher values indicate greater levels of skin hydration. Test results were compared to measurements from the other side of the face, which was not treated instead of referring to a normal range. A normal range does not exist for this measurement. Instead, the non-treated side of the face was used as a control to determine the normal level of skin hydration.
Time Frame	Baseline, 4 hrs. post 1st Treatment, Days 3, 7, and 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: Microsiemens
Baseline	378.06 (131.08)	392.09 (162.16)
4 hrs Post 1st Treatment	323.47 (154.30)	415.90 (197.57)
Day 3	420.97 (122.60)	465.25 (175.65)
Day 7	385.91 (156.69)	414.77 (154.46)
Day 14	401.98 (156.08)	418.51 (139.64)

5. Secondary Outcome

Title	Self Assessment of Burning
Description	The amount of burning on the left and right cheek of each panelist. The scale used to evaluate burning is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.00 (0.00)	0.00 (0.00)
Day 1	0.04 (0.20)	0.04 (0.19)
Day 2	0.04 (0.20)	0.04 (0.19)
Day 3	0.12 (0.33)	0.15 (0.36)
Day 6	0.12 (0.33)	0.56 (0.85)
Day 7	0.17 (0.48)	0.70 (0.87)
Day 8	0.17 (0.48)	0.50 (0.81)
Day 9	0.13 (0.45)	0.27 (0.67)
Day 10	0.13 (0.45)	0.31 (0.68)
Day 13	0.08 (0.28)	0.35 (0.75)
Day 14	0.08 (0.28)	0.19 (0.57)

6. Secondary Outcome

Title	Self Assessment of Stinging
Description	The amount of stinging on the left and right cheek of each panelist. The scale used to evaluate stinging is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of stinging were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.00 (0.00)	0.00 (0.00)
Day 1	0.08 (0.28)	0.00 (0.00)
Day 2	0.08 (0.28)	0.00 (0.00)
Day 3	0.12 (0.44)	0.04 (0.19)
Day 6	0.1 (0.4)	0.4 (0.8)
Day 7	0.17 (0.48)	0.30 (0.67)
Day 8	0.17 (0.48)	0.35 (0.69)
Day 9	0.13 (0.45)	0.15 (0.54)
Day 10	0.13 (0.45)	0.12 (0.43)
Day 13	0.13 (0.34)	0.19 (0.57)
Day 14	0.08 (0.28)	0.12 (0.43)

7. Secondary Outcome

Title	Self Assessment of Dryness
Description	The amount of dryness on the left and right cheek of each panelist. The scale used to evaluate dryness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.24 (0.44)	0.30 (0.54)
Day 1	0.2 (0.4)	0.19 (0.40)
Day 2	0.16 (0.37)	0.15 (0.36)
Day 3	0.24 (0.44)	0.2 (0.4)
Day 6	0.48 (0.77)	0.67 (0.96)
Day 7	0.54 (0.72)	0.70 (0.91)
Day 8	0.54 (0.78)	0.81 (1.02)
Day 9	0.54 (0.78)	0.85 (1.01)
Day 10	0.50 (0.78)	0.69 (0.88)
Day 13	0.50 (0.78)	0.73 (0.96)
Day 14	0.46 (0.72)	0.69 (1.05)

8. Secondary Outcome

Title	Self Assessment of Texture (Roughness)
Description	The amount of roughness on the left and right cheek of each panelist. The scale used to evaluate roughness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.28 (0.54)	0.15 (0.36)
Day 1	0.20 (0.50)	0.07 (0.27)
Day 2	0.16 (0.47)	0.07 (0.27)
Day 3	0.32 (0.69)	0.07 (0.27)
Day 6	0.28 (0.68)	0.33 (0.78)
Day 7	0.33 (0.76)	0.19 (0.56)
Day 8	0.25 (0.61)	0.3 (0.7)
Day 9	0.29 (0.69)	0.15 (0.46)
Day 10	0.29 (0.69)	0.15 (0.46)
Day 13	0.33 (0.70)	0.12 (0.43)
Day 14	0.29 (0.69)	0.15 (0.46)

9. Secondary Outcome

Title	Self Assessment of Pain
Description	The amount of pain on the left and right cheek of each panelist. The scale used to evaluate pain is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.00 (0.00)	0.00 (0.00)
Day 1	0.04 (0.20)	0.04 (0.19)
Day 2	0.04 (0.20)	0.00 (0.00)
Day 3	0.04 (0.20)	0.00 (0.00)
Day 6	0.04 (0.20)	0.1 (0.4)
Day 7	0.04 (0.20)	0.04 (0.19)
Day 8	0.04 (0.20)	0.04 (0.20)
Day 9	0.04 (0.20)	0.00 (0.00)
Day 10	0.04 (0.20)	0.00 (0.00)
Day 13	0.04 (0.20)	0.00 (0.00)
Day 14	0.04 (0.20)	0.00 (0.00)

10. Secondary Outcome

Title	Self Assessment of Crusting
Description	The amount of crusting on the left and right cheek of each panelist. The scale used to evaluate crusting is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.00 (0.00)	0.00 (0.00)
Day 1	0.00 (0.00)	0.00 (0.00)
Day 2	0.00 (0.00)	0.00 (0.00)
Day 3	0.00 (0.00)	0.00 (0.00)
Day 6	0.00 (0.00)	0.07 (0.38)
Day 7	0.00 (0.00)	0.04 (0.19)
Day 8	0.00 (0.00)	0.04 (0.20)
Day 9	0.00 (0.00)	0.04 (0.20)
Day 10	0.00 (0.00)	0.04 (0.20)
Day 13	0.00 (0.00)	0.00 (0.00)
Day 14	0.00 (0.00)	0.00 (0.00)

11. Secondary Outcome

Title	Self Assessment of Blistering
Description	The amount of blistering on the left and right cheek of each panelist. The scale used to evaluate blistering is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.00 (0.00)	0.00 (0.00)
Day 1	0.00 (0.00)	0.00 (0.00)
Day 2	0.00 (0.00)	0.00 (0.00)
Day 3	0.00 (0.00)	0.00 (0.00)
Day 6	0.00 (0.00)	0.07 (0.38)
Day 7	0.00 (0.00)	0.04 (0.19)
Day 8	0.00 (0.00)	0.00 (0.00)
Day 9	0.00 (0.00)	0.00 (0.00)
Day 10	0.00 (0.00)	0.00 (0.00)
Day 13	0.00 (0.00)	0.00 (0.00)
Day 14	0.00 (0.00)	0.00 (0.00)

12. Secondary Outcome

Title	Self Assessment of Oiliness
Description	The amount of oiliness on the left and right cheek of each panelist. The scale used to evaluate oiliness is: Scale Description: (scale: 0 = none to 3 = severe) Subject Self Assessments of burning were taken prior to product application on Days 0, 1, 2, 3, 6, 7, 8, 9, 10, 13 and 14.
Time Frame	Baseline, Day 1 through Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline	0.12 (0.33)	0.19 (0.40)
Day 1	0.08 (0.28)	0.11 (0.42)
Day 2	0.00 (0.00)	0.04 (0.19)
Day 3	0.08 (0.28)	0.11 (0.42)
Day 6	0.04 (0.20)	0.04 (0.19)
Day 7	0.00 (0.00)	0.07 (0.27)
Day 8	0.00 (0.00)	0.04 (0.20)
Day 9	0.00 (0.00)	0.08 (0.27)
Day 10	0.00 (0.00)	0.0 (0.2)
Day 13	0.00 (0.00)	0.12 (0.43)
Day 14	0.00 (0.00)	0.08 (0.27)

13. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product?
Description	The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How do you rate the comfort of the skin where you are currently treating with the study product? The subject replied using the following scale: - Very Comfortable; - Comfortable; - Somewhat Comfortable; - Somewhat Uncomfortable; - Uncomfortable
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.38 (1.13)	2.23 (1.24)

14. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day?
Description	The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: How compliant were you with applying the study product each and every day? The subject replied using the following scale: 0 - Not Compliant at all (<50%); - Mostly Compliant (50%-79%); - Very Compliant (80%-100%)
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.00 (0.00)	2.00 (0.00)

15. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product?
Description	The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Did you feel that your skin was hydrated and moisturized while you were on your study product? The subject replied using the following scale: 1 - Yes 0 - No
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
	0.58 (0.50)	0.54 (0.51)

16. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up?
Description	The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable; - Very Easy; - Easy; - Neutral; - Difficult; - Very Difficult
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.04 (1.12)	1.46 (1.14)

17. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product?
Description	The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: What was your overall satisfaction of the study product? The subject replied using the following scale: - Very Satisfied; - Satisfied; - Neutral; - Unsatisfied; - Very Unsatisfied
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.29 (1.04)	2.46 (1.03)

18. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product?
Description	The subject were presented with a questionnaire at day 14 (end of study) and was asked the following question: Was the study product easy to use with make-up? The subject replied using the following scale: 0 - Not Applicable; - Very Easy; - Easy; - Neutral; - Difficult; - Very Difficult
Time Frame	Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Duac	Epiduo
Arm/Group Description:	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide	Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
Overall Number of Participants Analyzed	25	27
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.17 (0.38)	1.00 (0.00)

Adverse Events

Time Frame	14 days
Adverse Event Reporting Description	Any study product-related AEs ongoing at the end of the treatment period were followed until they resolve, the condition stabilizes, the events are otherwise explained, or the subject is lost to follow-up. In addition, all SAEs were followed until resolution as previously stated for study product-related AEs.
Arm/Group Title	Duac		Epiduo
Arm/Group Description	Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide		Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
All-Cause Mortality
	Duac		Epiduo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Duac		Epiduo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0.00%)		0/27 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0.1%
	Duac		Epiduo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/25 (52.00%)		13/27 (48.15%)
General disorders
Toothache * 1	2/25 (8.00%)	2	1/27 (3.70%)	1
Sore throat * 1	2/25 (8.00%)	2	3/27 (11.11%)	3
Infections and infestations
Upper respiratory tract infection * 1	2/25 (8.00%)	2	0/27 (0.00%)	0
Seaonal allergies * 1	1/25 (4.00%)	1	0/27 (0.00%)	0
Earache * 1	0/25 (0.00%)	0	3/27 (11.11%)	3
Injury, poisoning and procedural complications
Stitches contusion * 1	0/25 (0.00%)	0	1/27 (3.70%)	1
Scratched cornea * 1	0/25 (0.00%)	0	1/27 (3.70%)	1
Musculoskeletal and connective tissue disorders
Joint stiffness * 1	0/25 (0.00%)	0	2/27 (7.41%)	2
Menstrual cramps * 1	3/25 (12.00%)	3	2/27 (7.41%)	2
Nervous system disorders
Headache * 1	4/25 (16.00%)	4	5/27 (18.52%)	5
Psychiatric disorders
Insomnia * 1	3/25 (12.00%)	3	0/27 (0.00%)	0
Skin and subcutaneous tissue disorders
Irritation * 1	2/25 (8.00%)	2	2/27 (7.41%)	2
* Indicates events were collected by non-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 NOT 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.

Results Point of Contact

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

• Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
• ClinicalTrials.gov Identifier: NCT00926367 History of Changes
• Other Study ID Numbers: C0000-405
• First Submitted: June 21, 2009
• First Posted: June 23, 2009
• Results First Submitted: September 7, 2010
• Results First Posted: August 4, 2011
• Last Update Posted: May 20, 2015