Trial Outcomes & Findings for Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne (NCT NCT00807014)

Last Updated: 2012-03-20

Results Overview

Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

169 participants

Primary outcome timeframe

Baseline (Week 0) and Week 2

Results posted on

2012-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Duac Gel Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Study STARTED	83	85
Overall Study COMPLETED	56	58
Overall Study NOT COMPLETED	27	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Duac Gel Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Overall Study Participant Considered Disease Cured	13	2
Overall Study Participant Considered Disease Not Cured	2	7
Overall Study Protocol Violation	2	8
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	9	7
Overall Study Recovery	1	0
Overall Study Missed Visit 2 Due to Personal Reasons	0	1

Baseline Characteristics

Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=85 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks	Total n=168 Participants Total of all reporting groups
Age Continuous	18.9 Years STANDARD_DEVIATION 5.3 • n=5 Participants	19.2 Years STANDARD_DEVIATION 5.3 • n=7 Participants	19.1 Years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	65 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	75 participants n=5 Participants	77 participants n=7 Participants	152 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Black	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized Mixed or Multiracial	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Race/Ethnicity, Customized Captured as "Other" on Case Report Form	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 0) and Week 2

Population: Intent-to-Treat (ITT) Population: all randomized participants (par.) who applied \>= 1 dose of study product. Missing values were imputed using the last observation carried forward (LOCF, i.e., the last available observation was used to estimate subsequent missing data points) method. 1 par. in the Differin arm had no QoL data and was not analyzed.

Outcome measures

Outcome measures
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=84 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire	-4.9 scores on a scale Standard Deviation 7.2	-1.1 scores on a scale Standard Deviation 8.4

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 12

Population: ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points). One participant in the Differin arm had no QoL data available and was thus excluded from analysis.

Outcome measures

Outcome measures
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=84 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire Symptomatic Domain	-7.4 scores on a scale Standard Deviation 13.0	-2.8 scores on a scale Standard Deviation 16.7
Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire Emotional Domain	-10.3 scores on a scale Standard Deviation 15.1	-5.4 scores on a scale Standard Deviation 13.5
Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire Functional Domain	-3.5 scores on a scale Standard Deviation 7.6	-0.1 scores on a scale Standard Deviation 8.0
Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire Global Score	-6.8 scores on a scale Standard Deviation 9.1	-2.6 scores on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12

Population: ITT Population. Missing values were imputed using the LOCF method.

Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions included papules, pustules, nodules, and cysts. Non-inflammatory lesions included closed comedones (whiteheads) and open comedones (blackheads). The total lesion count was calculated as the sum of inflammatory and non-inflammatory lesions. Change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline (Week 0).

Outcome measures

Outcome measures
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=85 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 1	-8.5 lesions Standard Deviation 12.8	-6.3 lesions Standard Deviation 15.6
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 2	-11.8 lesions Standard Deviation 17.3	-8.2 lesions Standard Deviation 17.9
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 4	-16.3 lesions Standard Deviation 20.2	-9.1 lesions Standard Deviation 16.8
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 8	-18.4 lesions Standard Deviation 21.7	-8.4 lesions Standard Deviation 30.7
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 12	-22.6 lesions Standard Deviation 23.0	-12.6 lesions Standard Deviation 33.3
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 1	-10.1 lesions Standard Deviation 12.5	-5.4 lesions Standard Deviation 8.9
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 2	-13.0 lesions Standard Deviation 13.2	-8.5 lesions Standard Deviation 11.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 4	-16.6 lesions Standard Deviation 14.4	-9.6 lesions Standard Deviation 11.7
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 8	-17.5 lesions Standard Deviation 16.1	-8.7 lesions Standard Deviation 14.4
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 12	-18.8 lesions Standard Deviation 17.8	-11.2 lesions Standard Deviation 15.5
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 1	-18.6 lesions Standard Deviation 18.1	-11.7 lesions Standard Deviation 19.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 2	-24.8 lesions Standard Deviation 21.0	-16.8 lesions Standard Deviation 23.7
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 4	-32.9 lesions Standard Deviation 25.2	-18.8 lesions Standard Deviation 21.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 8	-35.9 lesions Standard Deviation 29.0	-17.1 lesions Standard Deviation 36.8
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 12	-41.4 lesions Standard Deviation 32.3	-23.8 lesions Standard Deviation 40.5

SECONDARY outcome

Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12

Population: ITT Population. Missing values were imputed using the LOCF method. Some participants had no baseline lesions of an individual type; percent change from baseline is undefined for these participants. All participants, however, had at least one type of lesion; thus, all participants in the ITT Population were analyzed for total lesion count.

Lesions were counted on the entire face (defined as the area from the upper part of the jaw to the lower part of the hairline), excluding maculae and non-inflammatory lesions located on the nose or chin. Inflammatory lesions (IL) included papules, pustules, nodules, and cysts. Non-inflammatory lesions (NIL) included closed comedones (whiteheads) and open comedones (blackheads). Total lesion count was calculated as the sum of IL and NIL. Percent change from Baseline was calculated as the values at Weeks 1, 2, 4, 8, and 12 minus the value at Baseline divided by Baseline value \* 100.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 2

Population: ITT Population. Missing values were imputed using the LOCF method. One participant in the Differin group had no data available and was thus excluded from analysis.

Analyses were performed to determine whether there was a correlation between the total lesion count and either the global or subdomain Skindex-29 questionnaire scores. Correlations between the Skindex-29 questionnaire scores and total lesion count from Baseline to Week 2 were assessed using Spearman's correlation coefficients, which ranges from -1 to 1. A score of 0 denotes no correlation, a score approaching 1 denotes correlation, and a score approaching -1 denotes inverse correlation.

Outcome measures

Outcome measures
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=84 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 Functional Domain	0.042 Correlation coefficient	-0.094 Correlation coefficient
Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 Symptomatic Domain	0.166 Correlation coefficient	0.002 Correlation coefficient
Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 Emotional Domain	0.237 Correlation coefficient	-0.137 Correlation coefficient
Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 Global Score	0.223 Correlation coefficient	-0.087 Correlation coefficient

SECONDARY outcome

Timeframe: Start of treatment and Weeks 1, 2, 4, 8, and 12

Population: ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.

Global change in acne improvement was assessed by the investigator on a 7-point scale: 1=greatly worsened, 2=significantly worsened, 3=slightly worsened, 4=no change, 5=slightly improved, 6=significantly improved, or 7=greatly improved. Global change at the indicated week was assessed in terms of change from the previous week. Change at Week 2, for example, was an assessment of change from Week 1.

Outcome measures

Outcome measures
Measure	Duac Gel n=82 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=84 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 4, n=82, 83	5.7 scores on a scale Standard Deviation 1.2	5.3 scores on a scale Standard Deviation 1.1
Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 1, n=82, 82	5.2 scores on a scale Standard Deviation 1.0	4.9 scores on a scale Standard Deviation 0.9
Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 2, n=82, 83	5.4 scores on a scale Standard Deviation 1.0	5.3 scores on a scale Standard Deviation 0.9
Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 8, n=82, 83	5.8 scores on a scale Standard Deviation 1.3	5.1 scores on a scale Standard Deviation 1.4
Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 12, n=82, 84	6.0 scores on a scale Standard Deviation 1.2	5.5 scores on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Start of treatment and Weeks 1, 2, 4, 8, and 12

Population: ITT Population. Missing values were imputed using the LOCF method. Only those participants contributing data at the indicated time points were analyzed.

Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved.

Outcome measures

Outcome measures
Measure	Duac Gel n=82 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=84 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 1, n=82, 82	2.8 scores on a scale Standard Deviation 0.5	2.5 scores on a scale Standard Deviation 0.7
Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 2, n=82, 83	2.8 scores on a scale Standard Deviation 0.5	2.7 scores on a scale Standard Deviation 0.6
Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 4, n=82, 83	2.7 scores on a scale Standard Deviation 0.6	2.7 scores on a scale Standard Deviation 0.6
Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 8, n=82, 83	2.8 scores on a scale Standard Deviation 0.5	2.5 scores on a scale Standard Deviation 0.7
Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) Week 12, n=82, 84	2.8 scores on a scale Standard Deviation 0.5	2.6 scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12

Population: ITT Population. Missing values were imputed using the LOCF method.

The acne grade on the participant's face was assessed by the investigator using the LRAG, a photographic scale allowing for the assessment of the clinical status for acne severity for the face, back, and chest. It consists of a 12-grade scale (1, least severe; 12, most severe) for inflammatory visible lesions (les.). For non-inflammatory les., this scale comprises 3 photos of les. of increasing severity (grades 1-3). The scale provides a qualitative assessment of superficial/visible les. and provides consistency and inter-/intra-rater reliability. Grading was performed prior to les. counting.

Outcome measures

Outcome measures
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=85 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System Baseline (Week 0)	2.7 scores on a scale Standard Deviation 0.9	2.6 scores on a scale Standard Deviation 0.8
Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System Week 1	2.4 scores on a scale Standard Deviation 0.9	2.3 scores on a scale Standard Deviation 0.8
Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System Week 2	2.0 scores on a scale Standard Deviation 0.8	2.1 scores on a scale Standard Deviation 0.9
Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System Week 4	1.7 scores on a scale Standard Deviation 0.9	1.9 scores on a scale Standard Deviation 0.8
Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System Week 8	1.6 scores on a scale Standard Deviation 0.9	1.9 scores on a scale Standard Deviation 0.9
Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System Week 12	1.2 scores on a scale Standard Deviation 0.9	1.6 scores on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12

Population: ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).

Tolerance symptoms of peeling (flaking), erythema (redness of skin), and dryness were evaluated at each visit by the investigator. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.

Outcome measures

Outcome measures
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=85 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Peeling, Week 1	0.5 scores on a scale Standard Deviation 0.8	0.8 scores on a scale Standard Deviation 1.0
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Peeling, Week 2	0.2 scores on a scale Standard Deviation 0.5	0.6 scores on a scale Standard Deviation 1.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Peeling, Week 4	0.3 scores on a scale Standard Deviation 0.6	0.6 scores on a scale Standard Deviation 1.0
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Peeling, Week 8	0.1 scores on a scale Standard Deviation 0.4	0.5 scores on a scale Standard Deviation 0.9
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Peeling, Week 12	0.1 scores on a scale Standard Deviation 0.3	0.4 scores on a scale Standard Deviation 0.8
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Erythema, Week 1	0.6 scores on a scale Standard Deviation 1.0	0.8 scores on a scale Standard Deviation 1.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Erythema, Week 2	0.3 scores on a scale Standard Deviation 0.8	0.9 scores on a scale Standard Deviation 1.2
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Erythema, Week 4	0.3 scores on a scale Standard Deviation 0.6	0.7 scores on a scale Standard Deviation 1.0
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Erythema, Week 8	0.3 scores on a scale Standard Deviation 0.6	0.6 scores on a scale Standard Deviation 1.0
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Erythema, Week 12	0.2 scores on a scale Standard Deviation 0.5	0.4 scores on a scale Standard Deviation 0.9
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Dryness, Week 1	0.6 scores on a scale Standard Deviation 1.1	0.8 scores on a scale Standard Deviation 1.0
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Dryness, Week 2	0.4 scores on a scale Standard Deviation 0.8	0.8 scores on a scale Standard Deviation 1.2
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Dryness, Week 4	0.3 scores on a scale Standard Deviation 0.6	0.7 scores on a scale Standard Deviation 1.0
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Dryness, Week 8	0.2 scores on a scale Standard Deviation 0.5	0.6 scores on a scale Standard Deviation 1.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness Dryness, Week 12	0.1 scores on a scale Standard Deviation 0.4	0.4 scores on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12

Population: ITT Population. Missing values were imputed using the LOCF method (i.e., the last available observation was used to estimate subsequent missing data points).

Tolerance symptoms of itching and burning were evaluated at each visit by participants. Possible scores were: 0=absent, 1=mild intermittent, 2=mild persistent, 3=moderate intermittent, 4=moderate persistent, 5=severe intermittent, and 6=severe persistent.

Outcome measures

Outcome measures
Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=85 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Itching, Week 1	0.4 scores on a scale Standard Deviation 0.8	0.9 scores on a scale Standard Deviation 1.3
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Itching, Week 2	0.2 scores on a scale Standard Deviation 0.6	0.7 scores on a scale Standard Deviation 1.0
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Itching, Week 4	0.2 scores on a scale Standard Deviation 0.5	0.7 scores on a scale Standard Deviation 1.2
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Itching, Week 8	0.1 scores on a scale Standard Deviation 0.4	0.6 scores on a scale Standard Deviation 1.2
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Itching, Week 12	0.1 scores on a scale Standard Deviation 0.3	0.5 scores on a scale Standard Deviation 1.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Burning, Week 1	0.3 scores on a scale Standard Deviation 0.7	0.9 scores on a scale Standard Deviation 1.3
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Burning, Week 2	0.1 scores on a scale Standard Deviation 0.4	0.6 scores on a scale Standard Deviation 1.1
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Burning, Week 4	0.1 scores on a scale Standard Deviation 0.4	0.5 scores on a scale Standard Deviation 1.2
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Burning, Week 8	0.1 scores on a scale Standard Deviation 0.2	0.6 scores on a scale Standard Deviation 1.2
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning Burning, Week 12	0.0 scores on a scale Standard Deviation 0.2	0.5 scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Week 12 or Early Termination

Population: ITT Population. Some participants had no data available and were thus excluded from analysis.

Participants were evaluated for overall tolerance to study drug by the investigator at the end of the study (Week 12 or Early Termination). Participants were given the tolerance grades of poor, fair, good, or excellent.

Outcome measures

Outcome measures
Measure	Duac Gel n=80 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=83 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination Fair	4 participants	14 participants
Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination Poor	0 participants	5 participants
Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination Good	42 participants	47 participants
Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination Excellent	34 participants	17 participants

Adverse Events

Duac Gel

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Differin Gel

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duac Gel n=83 participants at risk Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=85 participants at risk Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
General disorders Application Site Erythema	2.4% 2/83	5.9% 5/85
General disorders Application Site Exfoliation	2.4% 2/83	4.7% 4/85
General disorders Application Site Pruritus	2.4% 2/83	4.7% 4/85
General disorders Application Site Dryness	1.2% 1/83	2.4% 2/85
General disorders Pyrexia	1.2% 1/83	0.00% 0/85
General disorders Application Site Irritation	0.00% 0/83	5.9% 5/85
General disorders Application Site Eczema	0.00% 0/83	4.7% 4/85
General disorders Application Site Dermatitis	0.00% 0/83	2.4% 2/85
General disorders Application Site Pain	0.00% 0/83	1.2% 1/85
Infections and infestations Nasopharyngitis	3.6% 3/83	2.4% 2/85
Infections and infestations Upper Respiratory Tract Infection	1.2% 1/83	1.2% 1/85
Infections and infestations Pharyngotonsillitis	1.2% 1/83	0.00% 0/85
Infections and infestations Tonsillitis	0.00% 0/83	2.4% 2/85
Infections and infestations Cystitis	0.00% 0/83	1.2% 1/85
Infections and infestations Infection	0.00% 0/83	1.2% 1/85
Infections and infestations Puncture Site Infection	0.00% 0/83	1.2% 1/85
Nervous system disorders Headache	3.6% 3/83	0.00% 0/85
Reproductive system and breast disorders Dysmenorrhea	1.2% 1/83	1.2% 1/85
Reproductive system and breast disorders Ovarian Cyst	1.2% 1/83	0.00% 0/85
Gastrointestinal disorders Rectal Hemorrhage	1.2% 1/83	0.00% 0/85
Gastrointestinal disorders Hemorrhoids	0.00% 0/83	1.2% 1/85
Psychiatric disorders Anxiety	1.2% 1/83	0.00% 0/85
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/83	1.2% 1/85
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/83	1.2% 1/85
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/83	1.2% 1/85
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/83	1.2% 1/85

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

Measure	Duac Gel n=83 Participants Duac gel (combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks	Differin Gel n=85 Participants Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 1, n=74, 73	-29.8 percent change in lesions Standard Deviation 36.3	-22.9 percent change in lesions Standard Deviation 52.8
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 2, n=74, 73	-38.4 percent change in lesions Standard Deviation 60.1	-26.5 percent change in lesions Standard Deviation 79.5
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 4, n=74, 73	-52.6 percent change in lesions Standard Deviation 50.7	-36.4 percent change in lesions Standard Deviation 62.1
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 8, n=74, 73	-59.5 percent change in lesions Standard Deviation 44.1	-32.8 percent change in lesions Standard Deviation 68.9
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Non-inflammatory Lesions, Week 12, n=74, 73	-69.7 percent change in lesions Standard Deviation 36.4	-45.5 percent change in lesions Standard Deviation 69.3
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 1, n=82, 84	-36.8 percent change in lesions Standard Deviation 32.1	-21.0 percent change in lesions Standard Deviation 45.1
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 2, n=82, 84	-53.0 percent change in lesions Standard Deviation 32.7	-36.4 percent change in lesions Standard Deviation 48.2
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 4, n=82, 84	-67.9 percent change in lesions Standard Deviation 27.7	-38.3 percent change in lesions Standard Deviation 50.6
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 8, n=82, 84	-67.6 percent change in lesions Standard Deviation 31.4	-33.8 percent change in lesions Standard Deviation 61.2
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Inflammatory Lesions, Week 12, n=82, 84	-72.4 percent change in lesions Standard Deviation 34.7	-46.5 percent change in lesions Standard Deviation 58.5
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 1, n=83, 85	-32.1 percent change in lesions Standard Deviation 28.6	-22.6 percent change in lesions Standard Deviation 34.8
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 2, n=83, 85	-46.3 percent change in lesions Standard Deviation 31.0	-33.6 percent change in lesions Standard Deviation 42.6
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 4, n=83, 85	-59.6 percent change in lesions Standard Deviation 30.8	-38.5 percent change in lesions Standard Deviation 40.7
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 8, n=83, 85	-65.7 percent change in lesions Standard Deviation 30.8	-35.2 percent change in lesions Standard Deviation 54.0
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts Total Lesions, Week 12, n=83, 85	-73.0 percent change in lesions Standard Deviation 26.7	-47.7 percent change in lesions Standard Deviation 53.2