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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single-blind, Multicenter, Parallel, Comparative, Randomized, Phase 4 Clinical Trial for the Evaluation of the Quality of Life, Efficacy and Tolerance of Duac® Gel Against Differin® Gel in the Topical Treatment of Mild to Moderate Acne Vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Duac Gel
* Drug: Differin gel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duac Gel<br>Duac Gel | Drug: Duac Gel<br>* Duac® Gel will be applied to the face once daily at night, for 12 weeks.<br>* Other names: Duac;|
| Active Comparator: Differin gel<br>Differin gel | Drug: Differin gel<br>* Differin Gel will be applied to the face once daily at night, for 12 weeks.<br>* Other names: Differin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline (Week 0) and Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline (Week 0) and Week 12 | 
| 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). | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 | 
| 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. | Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12 | 
| 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. | Baseline (Week 0) and Week 2 | 
| 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. | Start of treatment and Weeks 1, 2, 4, 8, and 12 | 
| 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. | Start of treatment and Weeks 1, 2, 4, 8, and 12 | 
| 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. | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 | 
| 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. | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 | 
| 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. | Baseline (Week 0); Weeks 1, 2, 4, 8, and 12 | 
| 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. | Week 12 or Early Termination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Differin, quality of life, Acne, Duac, Acne Vulgaris