A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne

• ClinicalTrials.gov Identifier: NCT00964223
• Recruitment Status: Completed
• First Posted: August 24, 2009
• Results First Posted: August 25, 2011
• Last Update Posted: November 23, 2016
• 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 gel (Duac® Topical Gel); Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)
• Enrollment: 28

Participant Flow

Recruitment Details	Clinical research centers
Pre-assignment Details

Arm/Group Title	All Study Participants
Arm/Group Description	Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Period Title: Split Face Treatment (Weeks 1 and 2)
Started	28
Completed	28
Not Completed	0
Period Title: Full Face Treatment (Weeks 5 and 8)
Started	28
Completed	27
Not Completed	1
Reason Not Completed
Lost to Follow-up	1

Baseline Characteristics

Arm/Group Title		All Study Participants
Arm/Group Description		Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Baseline Participants		28
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	28 participants
		29.6 (9.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants
	Female	24 85.7%
	Male	4 14.3%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	28 participants
Asian		2
Black or African American		11
White		15
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	28 participants
		28
Investigators Static Global Assessment (ISGA) [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	28 participants
Mild		2
Moderate		20
Severe		6
		[1] Measure Description: Patients with the following ISGA grades were eligible for enrollment on this study: 0, Clear: clear skin with no inflammatory lesions (IL) or non-inflammatory lesions (NIL); 1, Almost clear: rare NIL with no more than one small IL; 2, Mild: some NIL with no more than a few IL (papules/pustules only, no nodular lesions); 3, Moderate: up to many NIL and may have some IL, but no more than one small nodular lesion; 4, Severe: up to many NIL and IL, but no more than a few small nodular lesions; 5, Very severe: many NIL and IL and more than a few nodular lesions. May have cystic lesions.
Inflammatory Acne Lesion Count [1]; Mean (Standard Deviation); Unit of measure: Inflammatory Lesion
	Number Analyzed	28 participants
		21.5 (9.3)
		[1] Measure Description: Inflammatory acne lesion count at baseline (number of pustules and papules).
Non-Inflammatory Acne Lesion Count [1]; Mean (Standard Deviation); Unit of measure: Non-Inflammatory lesion
	Number Analyzed	28 participants
		33.0 (24.7)
		[1] Measure Description: Non-Inflammatory acne lesion count at baseline (number of whiteheads and blackheads)
Total Acne Lesion Count [1]; Mean (Standard Deviation); Unit of measure: Acne lesions
	Number Analyzed	28 participants
		54.5 (27.1)
		[1] Measure Description: Total acne lesion count (includes inflammatory and non-inflammatory lesions)

Outcome Measures

1. Primary Outcome

Title	Skin Dryness Score
Description	Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	0.15 (0.37)	0.46 (0.71)
Week 2	0.14 (0.36)	0.29 (0.53)

2. Primary Outcome

Title	Skin Peeling Score
Description	Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	0.15 (0.37)	0.54 (0.71)
Week 2	0.18 (0.39)	0.21 (0.50)

3. Primary Outcome

Title	Irritant/Allergic Contact Dermatitis Score
Description	Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None; Slight; Moderate; Intense
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	0.00 (0.00)	0.15 (0.46)
Week 2	0.00 (0.00)	0.00 (0.00)

4. Primary Outcome

Title	Erythema (Redness) Score
Description	Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	0.27 (0.53)	0.58 (0.81)
Week 2	0.18 (0.39)	0.36 (0.49)

5. Secondary Outcome

Title	Erythema (Redness) Score
Description	Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 5	0.26 (0.53)
Week 8	0.19 (0.40)

6. Secondary Outcome

Title	Skin Dryness Score
Description	Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 5	0.15 (0.46)
Week 8	0.00 (0.00)

7. Secondary Outcome

Title	Skin Peeling Score
Description	Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 5	0.00 (0.00)
Week 8	0.00 (0.00)

8. Secondary Outcome

Title	Irritant/Allergic Contact Dermatitis Score
Description	Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense.
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 5	0.04 (0.19)
Week 8	0.00 (0.00)

9. Secondary Outcome

Title	Investigator Static Global Assessment Score
Description	ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions.
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 5	2.63 (0.93)
Week 8	2.15 (1.03)

10. Secondary Outcome

Title	Inflammatory Acne Lesion Counts
Description	Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: inflammatory acne lesions
Week 5	8.44 (7.57)
Week 8	7.00 (9.03)

11. Secondary Outcome

Title	Non-Inflammatory Acne Lesion Counts
Description	Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: non-inflammatory acne lesions
Week 5	14.37 (11.20)
Week 8	10.81 (8.88)

12. Secondary Outcome

Title	Total Acne Lesion Counts
Description	Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Time Frame	Week 5, Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: total acne lesions
Week 5	22.81 (14.87)
Week 8	17.81 (14.04)

13. Secondary Outcome

Title	Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Description	Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame	Baseline, and Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Baseline	28.10 (17.01)
Week 8	21.72 (11.60)

14. Secondary Outcome

Title	Skindex-29 Quality of Life Questionnaire - Emotional Domain
Description	Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame	Baseline, and Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Baseline	44.29 (28.03)
Week 8	35.37 (26.03)

15. Secondary Outcome

Title	Skindex-29 Quality of Life Questionnaire - Functional Domain
Description	Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame	Baseline, and Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Baseline	14.06 (13.41)
Week 8	9.10 (10.39)

16. Secondary Outcome

Title	Skindex-29 Quality of Life Questionnaire - Global Score
Description	Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: "never" to "all the time", higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain.
Time Frame	Baseline, and Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Baseline	14.06 (13.41)
Week 8	9.10 (10.39)

17. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Redness
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	1.12 (1.24)	1.54 (1.36)
Week 2	0.78 (0.80)	1.00 (0.89)

18. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Redness
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.00 (1.14)

19. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Dryness
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	1.42 (1.36)	1.88 (1.82)
Week 2	1.31 (1.23)	1.58 (1.27)

20. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Dryness
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.22 (1.12)

21. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Burning
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	1.12 (1.24)	1.96 (1.61)
Week 2	0.73 (0.92)	1.11 (1.31)

22. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Burning
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	0.63 (0.93)

23. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Itching
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	1.19 (1.13)	1.42 (1.30)
Week 2	0.81 (1.02)	1.19 (1.27)

24. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Itching
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	0.63 (1.01)

25. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Scaling
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	0.77 (1.07)	1.15 (1.32)
Week 2	0.69 (0.93)	1.00 (1.17)

26. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Severity of Scaling
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	0.78 (1.28)

27. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Ease of Application of Product
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	1.46 (0.58)	1.50 (0.71)
Week 2	1.43 (0.50)	1.50 (0.84)

28. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Ease of Application of Product
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.26 (0.45)

29. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Comfort of Skin
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	2.38 (0.94)	2.58 (1.24)
Week 2	2.00 (0.86)	2.25 (1.14)

30. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Comfort of Skin
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.78 (0.85)

31. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit.

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Measure Type: Number; Unit of Measure: Participants
Week 1	17	8
Week 2	12	15

32. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.93 (1.24)

33. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	2.27 (0.78)	2.27 (0.72)
Week 2	2.14 (0.80)	2.07 (0.81)

34. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	2.07 (1.14)

35. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Compliance
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%).
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	1.96 (0.20)	1.93 (0.20)
Week 2	1.93 (0.26)	1.93 (0.26)

36. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Compliance
Description	Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Measure Type: Number; Unit of Measure: Participants
Yes	24
No	3

37. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Description	Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Measure Type: Number; Unit of Measure: Participants
Week 1 - Yes	18	16
Week 1 - No	8	10
Week 2 - Yes	19	18
Week 2 - No	8	9

38. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Description	Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Measure Type: Number; Unit of Measure: Participants
Yes	24
No	3

39. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Description	Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Measure Type: Number; Unit of Measure: Participants
Week 1 - Yes	19	15
Week 1 - No	5	10
Week 2 - Yes	16	18
Week 2 - No	10	9

40. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Description	Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Measure Type: Number; Unit of Measure: Participants
Yes	20
No	7

41. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT. All participants were asked to respond to the questionnaire.

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	2.31 (1.11)	2.38 (1.12)
Week 2	1.59 (0.87)	1.59 (0.87)

42. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Description	Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT. All participants were asked to respond to the questionnaire.

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.89 (0.96)

43. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Description	Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Time Frame	Week 1, Week 2

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel	Epiduo Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
Week 1	2.04 (0.92)	2.19 (1.06)
Week 2	2.21 (1.17)	2.32 (1.16)

44. Secondary Outcome

Title	Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Description	Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Duac Gel
Arm/Group Description:	Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Overall Number of Participants Analyzed	28
Mean (Standard Deviation); Unit of Measure: Units on a scale
	2.52 (1.37)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	All Study Participants
Arm/Group Description	Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
All-Cause Mortality
	All Study Participants
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	All Study Participants
	Affected / at Risk (%)
Total	0/28 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	All Study Participants
	Affected / at Risk (%)
Total	0/28 (0.00%)

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

Publications:

Gonzalez P, Vila R, Cirigliano M. The tolerability profile of clindamycin 1%/benzoyl peroxide 5% gel vs. adapalene 0.1%/benzoyl peroxide 2.5% gel for facial acne: results of a randomized, single-blind, split-face study. J Cosmet Dermatol. 2012 Dec;11(4):251-60. doi: 10.1111/jocd.12013.

• Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
• ClinicalTrials.gov Identifier: NCT00964223
• Other Study ID Numbers: 114547
• First Submitted: August 20, 2009
• First Posted: August 24, 2009
• Results First Submitted: September 7, 2010
• Results First Posted: August 25, 2011
• Last Update Posted: November 23, 2016