Acne Vulgaris
Conditions
Keywords
Differin, quality of life, Acne, Duac, Acne Vulgaris
Brief summary
The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.
Detailed description
Acne vulgaris is a chronic inflammatory disease of the pilosebaceous unit. It is characterized by the formation of comedones, papules, pustules, nodules, cysts, maculae and scars, generally located on the face, chest and back. Acne pathogenesis is recognized as multifactorial. Acne vulgaris is the most common dermatological disorder. It affects approximately 85% individuals at some point in their lives, generally between 12 and 24 years of age. Although acne is prevalent within this age range, it can persist for many years and its long-term physical and psychological implications can be significant. There are several medicinal products used to treat acne. However, the therapeutic challenge remains, therefore it is essential to continue investigating effective strategies for the treatment of this disease.
Interventions
DRUGDuac Gel
Duac® Gel will be applied to the face once daily at night, for 12 weeks.
DRUGDifferin gel
Differin Gel will be applied to the face once daily at night, for 12 weeks.
Sponsors
GlaxoSmithKline
Stiefel, a GSK Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with mild to moderate acne vulgaris on the face,. * Subjects of either sex aged between 12 and 39 years, inclusive. * Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.
Exclusion criteria
* Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view * Subjects using anti-androgen containing contraceptives. * Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy. * Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study. * Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator. * Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis. * Subjects with a history of photosensitivity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire | Baseline (Week 0) and Week 2 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 | 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). |
| Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 | 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. |
| Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Baseline (Week 0) and Week 2 | 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. |
| 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) | Start of treatment and Weeks 1, 2, 4, 8, and 12 | 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. |
| Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire | Baseline (Week 0) and Week 12 | 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). |
| Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 | 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. |
| Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 | 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. |
| Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 | 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. |
| Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Week 12 or Early Termination | 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. |
| 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) | Start of treatment and Weeks 1, 2, 4, 8, and 12 | Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 83 |
| Differin Gel Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks | 85 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Missed Visit 2 Due to Personal Reasons | 0 | 1 |
| 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 | Recovery | 1 | 0 |
Baseline characteristics
| Characteristic | Duac Gel | Differin Gel | Total |
|---|---|---|---|
| Age Continuous | 18.9 Years STANDARD_DEVIATION 5.3 | 19.2 Years STANDARD_DEVIATION 5.3 | 19.1 Years STANDARD_DEVIATION 5.3 |
| Race/Ethnicity, Customized Asian | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Black | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Captured as Other on Case Report Form | 3 participants | 4 participants | 7 participants |
| Race/Ethnicity, Customized Caucasian | 75 participants | 77 participants | 152 participants |
| Race/Ethnicity, Customized Mixed or Multiracial | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 59 Participants | 65 Participants | 124 Participants |
| Sex: Female, Male Male | 24 Participants | 20 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 83 | 22 / 85 |
| serious Total, serious adverse events | 0 / 83 | 0 / 85 |
Outcome results
Primary
Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire
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).
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duac Gel | 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 |
| Differin Gel | Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire | -1.1 scores on a scale | Standard Deviation 8.4 |
p-value: <0.001ANCOVA
Secondary
Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Functional Domain | 0.042 Correlation coefficient |
| Duac Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Symptomatic Domain | 0.166 Correlation coefficient |
| Duac Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Emotional Domain | 0.237 Correlation coefficient |
| Duac Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Global Score | 0.223 Correlation coefficient |
| Differin Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Global Score | -0.087 Correlation coefficient |
| Differin Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Functional Domain | -0.094 Correlation coefficient |
| Differin Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Emotional Domain | -0.137 Correlation coefficient |
| Differin Gel | Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 | Symptomatic Domain | 0.002 Correlation coefficient |
Secondary
Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System
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.
Time frame: Baseline (Week 0); Weeks 1, 2, 4, 8, and 12
Population: ITT Population. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | Week 8 | 1.9 scores on a scale | Standard Deviation 0.9 |
| Differin Gel | Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | Baseline (Week 0) | 2.6 scores on a scale | Standard Deviation 0.8 |
| Differin Gel | Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | Week 4 | 1.9 scores on a scale | Standard Deviation 0.8 |
| Differin Gel | Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | Week 1 | 2.3 scores on a scale | Standard Deviation 0.8 |
| Differin Gel | Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | Week 12 | 1.6 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System | Week 2 | 2.1 scores on a scale | Standard Deviation 0.9 |
Secondary
Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | 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 | -2.6 scores on a scale | Standard Deviation 9.8 |
| Differin Gel | 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 | -2.8 scores on a scale | Standard Deviation 16.7 |
| Differin Gel | 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 | -0.1 scores on a scale | Standard Deviation 8 |
| Differin Gel | 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 | -5.4 scores on a scale | Standard Deviation 13.5 |
Secondary
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts
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).
Time frame: Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12
Population: ITT Population. Missing values were imputed using the LOCF method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Total Lesions, Week 12 | -23.8 lesions | Standard Deviation 40.5 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Inflammatory Lesions, Week 4 | -9.6 lesions | Standard Deviation 11.7 |
| Differin Gel | 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 | -6.3 lesions | Standard Deviation 15.6 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Total Lesions, Week 2 | -16.8 lesions | Standard Deviation 23.7 |
| Differin Gel | 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 | -8.2 lesions | Standard Deviation 17.9 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Inflammatory Lesions, Week 8 | -8.7 lesions | Standard Deviation 14.4 |
| Differin Gel | 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 | -9.1 lesions | Standard Deviation 16.8 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Total Lesions, Week 8 | -17.1 lesions | Standard Deviation 36.8 |
| Differin Gel | 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 | -8.4 lesions | Standard Deviation 30.7 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Inflammatory Lesions, Week 12 | -11.2 lesions | Standard Deviation 15.5 |
| Differin Gel | 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 | -12.6 lesions | Standard Deviation 33.3 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Total Lesions, Week 4 | -18.8 lesions | Standard Deviation 21.1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Inflammatory Lesions, Week 1 | -5.4 lesions | Standard Deviation 8.9 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Total Lesions, Week 1 | -11.7 lesions | Standard Deviation 19.1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts | Inflammatory Lesions, Week 2 | -8.5 lesions | Standard Deviation 11.1 |
Secondary
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Burning, Week 4 | 0.5 scores on a scale | Standard Deviation 1.2 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Itching, Week 1 | 0.9 scores on a scale | Standard Deviation 1.3 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Burning, Week 1 | 0.9 scores on a scale | Standard Deviation 1.3 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Itching, Week 2 | 0.7 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Burning, Week 12 | 0.5 scores on a scale | Standard Deviation 1.1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Itching, Week 4 | 0.7 scores on a scale | Standard Deviation 1.2 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Burning, Week 2 | 0.6 scores on a scale | Standard Deviation 1.1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Itching, Week 8 | 0.6 scores on a scale | Standard Deviation 1.2 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Burning, Week 8 | 0.6 scores on a scale | Standard Deviation 1.2 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning | Itching, Week 12 | 0.5 scores on a scale | Standard Deviation 1.1 |
Secondary
Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Dryness, Week 12 | 0.4 scores on a scale | Standard Deviation 0.9 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Peeling, Week 1 | 0.8 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Peeling, Week 2 | 0.6 scores on a scale | Standard Deviation 1.1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Peeling, Week 4 | 0.6 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Peeling, Week 8 | 0.5 scores on a scale | Standard Deviation 0.9 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Peeling, Week 12 | 0.4 scores on a scale | Standard Deviation 0.8 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Erythema, Week 1 | 0.8 scores on a scale | Standard Deviation 1.1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Erythema, Week 2 | 0.9 scores on a scale | Standard Deviation 1.2 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Erythema, Week 4 | 0.7 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Erythema, Week 8 | 0.6 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Erythema, Week 12 | 0.4 scores on a scale | Standard Deviation 0.9 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Dryness, Week 1 | 0.8 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Dryness, Week 2 | 0.8 scores on a scale | Standard Deviation 1.2 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Dryness, Week 4 | 0.7 scores on a scale | Standard Deviation 1 |
| Differin Gel | Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness | Dryness, Week 8 | 0.6 scores on a scale | Standard Deviation 1.1 |
Secondary
Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | 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 | -47.7 percent change in lesions | Standard Deviation 53.2 |
| Differin Gel | 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 | -22.9 percent change in lesions | Standard Deviation 52.8 |
| Differin Gel | 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 | -26.5 percent change in lesions | Standard Deviation 79.5 |
| Differin Gel | 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 | -36.4 percent change in lesions | Standard Deviation 62.1 |
| Differin Gel | 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 | -32.8 percent change in lesions | Standard Deviation 68.9 |
| Differin Gel | 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 | -45.5 percent change in lesions | Standard Deviation 69.3 |
| Differin Gel | 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 | -21.0 percent change in lesions | Standard Deviation 45.1 |
| Differin Gel | 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 | -36.4 percent change in lesions | Standard Deviation 48.2 |
| Differin Gel | 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 | -38.3 percent change in lesions | Standard Deviation 50.6 |
| Differin Gel | 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 | -33.8 percent change in lesions | Standard Deviation 61.2 |
| Differin Gel | 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 | -46.5 percent change in lesions | Standard Deviation 58.5 |
| Differin Gel | 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 | -22.6 percent change in lesions | Standard Deviation 34.8 |
| Differin Gel | 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 | -33.6 percent change in lesions | Standard Deviation 42.6 |
| Differin Gel | 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 | -38.5 percent change in lesions | Standard Deviation 40.7 |
| Differin Gel | 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 | -35.2 percent change in lesions | Standard Deviation 54 |
Secondary
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)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | 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 | 5.1 scores on a scale | Standard Deviation 1.4 |
| Differin Gel | 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 | 5.3 scores on a scale | Standard Deviation 1.1 |
| Differin Gel | 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 | 4.9 scores on a scale | Standard Deviation 0.9 |
| Differin Gel | 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 | 5.5 scores on a scale | Standard Deviation 1.3 |
| Differin Gel | 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 | 5.3 scores on a scale | Standard Deviation 0.9 |
Secondary
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)
Participants self-evaluated their acne improvement on a 3-point scale: 1=worsened, 2=no changes, and 3=improved.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Duac Gel | 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 |
| Differin Gel | 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 | 2.6 scores on a scale | Standard Deviation 0.7 |
| Differin Gel | 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 | 2.5 scores on a scale | Standard Deviation 0.7 |
| Differin Gel | 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 | 2.7 scores on a scale | Standard Deviation 0.6 |
| Differin Gel | 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 |
| Differin Gel | 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 | 2.5 scores on a scale | Standard Deviation 0.7 |
Secondary
Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination
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.
Time frame: Week 12 or Early Termination
Population: ITT Population. Some participants had no data available and were thus excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duac Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Poor | 0 participants |
| Duac Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Fair | 4 participants |
| Duac Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Good | 42 participants |
| Duac Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Excellent | 34 participants |
| Differin Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Excellent | 17 participants |
| Differin Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Poor | 5 participants |
| Differin Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Good | 47 participants |
| Differin Gel | Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination | Fair | 14 participants |