Trial Outcomes & Findings for A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne (NCT NCT00964223)
NCT ID: NCT00964223
Last Updated: 2016-11-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
Week 1, Week 2
Results posted on
2016-11-23
Participant Flow
Clinical research centers
Participant milestones
| Measure |
All Study Participants
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.
|
|---|---|
|
Split Face Treatment (Weeks 1 and 2)
STARTED
|
28
|
|
Split Face Treatment (Weeks 1 and 2)
COMPLETED
|
28
|
|
Split Face Treatment (Weeks 1 and 2)
NOT COMPLETED
|
0
|
|
Full Face Treatment (Weeks 5 and 8)
STARTED
|
28
|
|
Full Face Treatment (Weeks 5 and 8)
COMPLETED
|
27
|
|
Full Face Treatment (Weeks 5 and 8)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Study Participants
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.
|
|---|---|
|
Full Face Treatment (Weeks 5 and 8)
Lost to Follow-up
|
1
|
Baseline Characteristics
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Baseline characteristics by cohort
| Measure |
All Study Participants
n=28 Participants
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.
|
|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Investigators Static Global Assessment (ISGA)
Mild
|
2 Participants
n=5 Participants
|
|
Investigators Static Global Assessment (ISGA)
Moderate
|
20 Participants
n=5 Participants
|
|
Investigators Static Global Assessment (ISGA)
Severe
|
6 Participants
n=5 Participants
|
|
Inflammatory Acne Lesion Count
|
21.5 Inflammatory Lesion
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Non-Inflammatory Acne Lesion Count
|
33.0 Non-Inflammatory lesion
STANDARD_DEVIATION 24.7 • n=5 Participants
|
|
Total Acne Lesion Count
|
54.5 Acne lesions
STANDARD_DEVIATION 27.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 1, Week 2Population: Intent-to-Treat (ITT) Population
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Skin Dryness Score
Week 1
|
0.15 Units on a scale
Standard Deviation 0.37
|
0.46 Units on a scale
Standard Deviation 0.71
|
|
Skin Dryness Score
Week 2
|
0.14 Units on a scale
Standard Deviation 0.36
|
0.29 Units on a scale
Standard Deviation 0.53
|
PRIMARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Skin Peeling Score
Week 1
|
0.15 Units on a scale
Standard Deviation 0.37
|
0.54 Units on a scale
Standard Deviation 0.71
|
|
Skin Peeling Score
Week 2
|
0.18 Units on a scale
Standard Deviation 0.39
|
0.21 Units on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Week 1, Week 2Population: ITT
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
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Irritant/Allergic Contact Dermatitis Score
Week 1
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.15 Units on a scale
Standard Deviation 0.46
|
|
Irritant/Allergic Contact Dermatitis Score
Week 2
|
0.00 Units on a scale
Standard Deviation 0.00
|
0.00 Units on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Erythema (Redness) Score
Week 1
|
0.27 Units on a scale
Standard Deviation 0.53
|
0.58 Units on a scale
Standard Deviation 0.81
|
|
Erythema (Redness) Score
Week 2
|
0.18 Units on a scale
Standard Deviation 0.39
|
0.36 Units on a scale
Standard Deviation 0.49
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Erythema (Redness) Score
Week 5
|
0.26 Units on a scale
Standard Deviation 0.53
|
—
|
|
Erythema (Redness) Score
Week 8
|
0.19 Units on a scale
Standard Deviation 0.40
|
—
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Skin Dryness Score
Week 5
|
0.15 Units on a scale
Standard Deviation 0.46
|
—
|
|
Skin Dryness Score
Week 8
|
0.00 Units on a scale
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Skin Peeling Score
Week 5
|
0.00 Units on a scale
Standard Deviation 0.00
|
—
|
|
Skin Peeling Score
Week 8
|
0.00 Units on a scale
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Irritant/Allergic Contact Dermatitis Score
Week 5
|
0.04 Units on a scale
Standard Deviation 0.19
|
—
|
|
Irritant/Allergic Contact Dermatitis Score
Week 8
|
0.00 Units on a scale
Standard Deviation 0.00
|
—
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Investigator Static Global Assessment Score
Week 5
|
2.63 Units on a scale
Standard Deviation 0.93
|
—
|
|
Investigator Static Global Assessment Score
Week 8
|
2.15 Units on a scale
Standard Deviation 1.03
|
—
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
Total number of inflammatory acne lesions (pustules, papules) at each timepoint.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Inflammatory Acne Lesion Counts
Week 5
|
8.44 inflammatory acne lesions
Standard Deviation 7.57
|
—
|
|
Inflammatory Acne Lesion Counts
Week 8
|
7.00 inflammatory acne lesions
Standard Deviation 9.03
|
—
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Non-Inflammatory Acne Lesion Counts
Week 5
|
14.37 non-inflammatory acne lesions
Standard Deviation 11.20
|
—
|
|
Non-Inflammatory Acne Lesion Counts
Week 8
|
10.81 non-inflammatory acne lesions
Standard Deviation 8.88
|
—
|
SECONDARY outcome
Timeframe: Week 5, Week 8Population: ITT
Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads),
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Total Acne Lesion Counts
Week 5
|
22.81 total acne lesions
Standard Deviation 14.87
|
—
|
|
Total Acne Lesion Counts
Week 8
|
17.81 total acne lesions
Standard Deviation 14.04
|
—
|
SECONDARY outcome
Timeframe: Baseline, and Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Baseline
|
28.10 Units on a scale
Standard Deviation 17.01
|
—
|
|
Skindex-29 Quality of Life Questionnaire - Symptomatic Domain
Week 8
|
21.72 Units on a scale
Standard Deviation 11.60
|
—
|
SECONDARY outcome
Timeframe: Baseline, and Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Baseline
|
44.29 Units on a scale
Standard Deviation 28.03
|
—
|
|
Skindex-29 Quality of Life Questionnaire - Emotional Domain
Week 8
|
35.37 Units on a scale
Standard Deviation 26.03
|
—
|
SECONDARY outcome
Timeframe: Baseline, and Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Skindex-29 Quality of Life Questionnaire - Functional Domain
Baseline
|
14.06 Units on a scale
Standard Deviation 13.41
|
—
|
|
Skindex-29 Quality of Life Questionnaire - Functional Domain
Week 8
|
9.10 Units on a scale
Standard Deviation 10.39
|
—
|
SECONDARY outcome
Timeframe: Baseline, and Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Skindex-29 Quality of Life Questionnaire - Global Score
Baseline
|
14.06 Units on a scale
Standard Deviation 13.41
|
—
|
|
Skindex-29 Quality of Life Questionnaire - Global Score
Week 8
|
9.10 Units on a scale
Standard Deviation 10.39
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Redness
Week 1
|
1.12 Units on a scale
Standard Deviation 1.24
|
1.54 Units on a scale
Standard Deviation 1.36
|
|
Product Acceptability and Preference Questionnaire - Severity of Redness
Week 2
|
0.78 Units on a scale
Standard Deviation 0.80
|
1.00 Units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Redness
|
1.00 Units on a scale
Standard Deviation 1.14
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Dryness
Week 1
|
1.42 Units on a scale
Standard Deviation 1.36
|
1.88 Units on a scale
Standard Deviation 1.82
|
|
Product Acceptability and Preference Questionnaire - Severity of Dryness
Week 2
|
1.31 Units on a scale
Standard Deviation 1.23
|
1.58 Units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Dryness
|
1.22 Units on a scale
Standard Deviation 1.12
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Burning
Week 1
|
1.12 Units on a scale
Standard Deviation 1.24
|
1.96 Units on a scale
Standard Deviation 1.61
|
|
Product Acceptability and Preference Questionnaire - Severity of Burning
Week 2
|
0.73 Units on a scale
Standard Deviation 0.92
|
1.11 Units on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Burning
|
0.63 Units on a scale
Standard Deviation 0.93
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Itching
Week 1
|
1.19 Units on a scale
Standard Deviation 1.13
|
1.42 Units on a scale
Standard Deviation 1.30
|
|
Product Acceptability and Preference Questionnaire - Severity of Itching
Week 2
|
0.81 Units on a scale
Standard Deviation 1.02
|
1.19 Units on a scale
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Itching
|
0.63 Units on a scale
Standard Deviation 1.01
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Scaling
Week 1
|
0.77 Units on a scale
Standard Deviation 1.07
|
1.15 Units on a scale
Standard Deviation 1.32
|
|
Product Acceptability and Preference Questionnaire - Severity of Scaling
Week 2
|
0.69 Units on a scale
Standard Deviation 0.93
|
1.00 Units on a scale
Standard Deviation 1.17
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Severity of Scaling
|
0.78 Units on a scale
Standard Deviation 1.28
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Week 1
|
1.46 Units on a scale
Standard Deviation 0.58
|
1.50 Units on a scale
Standard Deviation 0.71
|
|
Product Acceptability and Preference Questionnaire - Ease of Application of Product
Week 2
|
1.43 Units on a scale
Standard Deviation 0.50
|
1.50 Units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Application of Product
|
1.26 Units on a scale
Standard Deviation 0.45
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Comfort of Skin
Week 1
|
2.38 Units on a scale
Standard Deviation 0.94
|
2.58 Units on a scale
Standard Deviation 1.24
|
|
Product Acceptability and Preference Questionnaire - Comfort of Skin
Week 2
|
2.00 Units on a scale
Standard Deviation 0.86
|
2.25 Units on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Comfort of Skin
|
1.78 Units on a scale
Standard Deviation 0.85
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT. Some participants missed a visit and therefore were not included in the number of participants analyzed for that visit.
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Week 1
|
17 Participants
|
8 Participants
|
|
Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With?
Week 2
|
12 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past
|
1.93 Units on a scale
Standard Deviation 1.24
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Week 1
|
2.27 Units on a scale
Standard Deviation 0.78
|
2.27 Units on a scale
Standard Deviation 0.72
|
|
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
Week 2
|
2.14 Units on a scale
Standard Deviation 0.80
|
2.07 Units on a scale
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products
|
2.07 Units on a scale
Standard Deviation 1.14
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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%).
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Compliance
Week 1
|
1.96 Units on a scale
Standard Deviation 0.20
|
1.93 Units on a scale
Standard Deviation 0.20
|
|
Product Acceptability and Preference Questionnaire - Compliance
Week 2
|
1.93 Units on a scale
Standard Deviation 0.26
|
1.93 Units on a scale
Standard Deviation 0.26
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Compliance
Yes
|
24 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Compliance
No
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Week 2 - Yes
|
19 Participants
|
18 Participants
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Week 1 - Yes
|
18 Participants
|
16 Participants
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Week 1 - No
|
8 Participants
|
10 Participants
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Week 2 - No
|
8 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No).
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
Yes
|
24 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin
No
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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).
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Week 1 - Yes
|
19 Participants
|
15 Participants
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Week 1 - No
|
5 Participants
|
10 Participants
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Week 2 - Yes
|
16 Participants
|
18 Participants
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Week 2 - No
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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).
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
Yes
|
20 Participants
|
—
|
|
Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment
No
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT. All participants were asked to respond to the questionnaire.
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Week 1
|
2.31 Units on a scale
Standard Deviation 1.11
|
2.38 Units on a scale
Standard Deviation 1.12
|
|
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
Week 2
|
1.59 Units on a scale
Standard Deviation 0.87
|
1.59 Units on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: Week 8Population: ITT. All participants were asked to respond to the questionnaire.
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up
|
1.89 Units on a scale
Standard Deviation 0.96
|
—
|
SECONDARY outcome
Timeframe: Week 1, Week 2Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
n=28 Participants
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Week 1
|
2.04 Units on a scale
Standard Deviation 0.92
|
2.19 Units on a scale
Standard Deviation 1.06
|
|
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
Week 2
|
2.21 Units on a scale
Standard Deviation 1.17
|
2.32 Units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Week 8Population: ITT
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.
Outcome measures
| Measure |
Duac Gel
n=28 Participants
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.
|
Epiduo Gel
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.
|
|---|---|---|
|
Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product
|
2.52 Units on a scale
Standard Deviation 1.37
|
—
|
Adverse Events
All Study Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER