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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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:
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
Recruitment Details Clinical research centers
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide 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
Arm/Group Title All Study Participants
Hide 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
Hide 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)
1.Primary Outcome
Title Skin Dryness Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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

  1. Slight
  2. Moderate
  3. Intense
Time Frame Week 1, Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide Description Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Time Frame Week 5, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide Description Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Time Frame Week 5, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide Description Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Time Frame Week 5, Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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?
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. All participants were asked to respond to the questionnaire.
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT. All participants were asked to respond to the questionnaire.
Arm/Group Title Duac Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel Epiduo Gel
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Duac Gel
Hide 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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Study Participants
Hide 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   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide 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%) 
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 ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00964223     History of Changes
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