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

Study Overview
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Brief Summary
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Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.

Detailed Description
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Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3 subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks. Blinding This is an investigator-blinded study; therefore, subjects and study-center staff will not be blinded to study treatment allocation (ie, left vs. right side application). During the first 2 weeks, the investigator will be unaware of which study product is being used on either side of the face. Subjects and study-center staff will be instructed not to reveal study treatment allocation to the investigator. Subjects will be instructed not to use study product in the presence of the investigator.

Official Title
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A Single-blind, Randomized, Comparative Split-face Study Evaluating the Tolerability of Clindamycin and Benzoyl Peroxide Gel to Benzoyl Peroxide/Adapalene Gel in the Treatment of Acne Vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)
* Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris. Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product. Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed. Exclusion Criteria: Female subjects who are pregnant, trying to become pregnant or breastfeeding. Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris. Facial hair that may obscure the accurate assessment of acne grade. History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms. Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively. Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable. Use of systemic retinoids within the past 6 months. Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity. Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents. Use of topical anti-acne medications within the past 2 weeks. Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.

Ages Eligible for Study
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Minimum Age: 18 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>Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. | Drug: Clindamycin and benzoyl peroxide gel (Duac® Topical Gel)<br>* Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.<br>* Other names: Duac® Topical Gel;|
| Active Comparator: Epiduo gel<br>Subjects will apply Duac gel once a day to one-half of their face and and apply Epiduo gel on the other side of their face once daily for the first 2 weeks. | Drug: benzoyl peroxide and adapalene gel (EPIDUO™ Gel)<br>* Subjects will apply Duac(clindamycin and benzoyl peroxide) gel to one-half of their face and and apply Epiduo (benzoyl peroxide/adapalene) gel on the other side of their face once a day for the first 2 weeks. Starting at week 2, subjects will apply Duac (benzoyl peroxide/clindamycin gel) to the entire face for an additional 6 weeks.<br>* Other names: EPIDUO™ Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Dryness Score | Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 1, Week 2 | 
| Skin Peeling Score | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; Intense, 3. | Week 1, Week 2 | 
| Irritant/Allergic Contact Dermatitis Score | Signs and symptoms of tolerability (erythema, peeling, dryness, and irritant/allergic contact dermatitis) on the face. Erythema,peeling, and dryness were graded using the following scale: 0 None Slight Moderate Intense | Week 1, Week 2 | 
| Erythema (Redness) Score | Investigator assessment of tolerability (irritant/allergic contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 1, Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema (Redness) Score | Investigator assessment of tolerability (erythema) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 5, Week 8 | 
| Skin Dryness Score | Investigator assessment of tolerability (skin dryness) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 5, Week 8 | 
| Skin Peeling Score | Investigator assessment of tolerability (skin peeling) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 5, Week 8 | 
| Irritant/Allergic Contact Dermatitis Score | Investigator assessment of tolerability (contact dermatitis) on the face. Erythema, peeling, and dryness were graded using the following Investigator Assessment of Tolerability scale: 0, None; 1, Slight; 2, Moderate; 3, Intense. | Week 5, Week 8 | 
| Investigator Static Global Assessment Score | ISGA is evaluated using the following scale: 0, clear, clear skin with no lesions; 1, almost clear, rare non-inflammatory lesions; 2, mild, some non-inflammatory lesions with no more than a few inflammatory lesions but no nodular lesions; 3, moderate, up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than 1 small nodular lesion; 4, severe, up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions; 5, very severe, many non-inflammatory and inflammatory lesions and more than a few nodular lesions. May have cystic lesions. | Week 5, Week 8 | 
| Inflammatory Acne Lesion Counts | Total number of inflammatory acne lesions (pustules, papules) at each timepoint. | Week 5, Week 8 | 
| Non-Inflammatory Acne Lesion Counts | Total number of non-inflammatory acne lesions (whiteheads and blackheads) at each timepoint. | Week 5, Week 8 | 
| Total Acne Lesion Counts | Total acne lesion counts - includes both inflammatory acne lesions (pustules, papules), noninflammatory lesions (whiteheads and blackheads), | Week 5, Week 8 | 
| Skindex-29 Quality of Life Questionnaire - Symptomatic Domain | Skindex-29 Quality of Life (QoL) Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 | 
| Skindex-29 Quality of Life Questionnaire - Emotional Domain | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 | 
| Skindex-29 Quality of Life Questionnaire - Functional Domain | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. Scores range from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 | 
| Skindex-29 Quality of Life Questionnaire - Global Score | Skindex-29 Quality of Life (QoL)Questionnaire used in dermatological disease consisting of 29 questions covering: burden of symptoms, functioning and emotional domains, with a five-point scale from: never to all the time, higher scores for each domain indicate worse effects on QoL. The Global Score ranges from 0 to 100. Higher scores indicate worse QoL for that domain. | Baseline, and Week 8 | 
| Product Acceptability and Preference Questionnaire - Severity of Redness | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Severity of Redness | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Severity of Dryness | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Severity of Dryness | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Severity of Burning | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Severity of Burning | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Severity of Itching | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Severity of Itching | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Severity of Scaling | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Severity of Scaling | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, none; 1, very minimal; 2, mild; 3, moderate; 4, severe; 5, very severe. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Ease of Application of Product | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Ease of Application of Product | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very easy; 2, easy; 3, neutral; 4, difficult; 5, very difficult. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Comfort of Skin | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Comfort of Skin | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very comfortable; 2, comfortable; 3, somewhat comfortable; 4, somewhat uncomfortable; 5, uncomfortable. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? | Product Acceptability and Preference Questionnaire was completed by the subject at week 1 and week 2 asking which study product they were more satisfied with: Duac or Epiduo. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, more satisfied; 2, somewhat more satisfied; 3, neither satisfied or dissatisfied; 4, more satisfied; 5, more dissatisfied. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, highly favorable; 2, favorable; 3, neutral; 4, unfavorable; 5, highly unfavorable. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Compliance | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, non-compliant (< 50% of the week); 1, mostly compliant (50-79%); 2, very compliant (80-100%). | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Compliance | Subject response to question regarding use of the product every day or not at week 8 time point answering Yes or No | Week 8 | 
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin | Subject response to question: did you feel that your skin was hydrated and moisturized while you on your study product? (Yes or No). | Week 8 | 
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment | Subject response to the following question: If you were to choose to continue treatment for your acne, which treatment would you choose? (Yes or No). | Week 8 | 
| Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up | Measure Description Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 0, not applicable; 1, very easy; 2, easy; 3, neutral; 4, difficult. | Week 8 | 
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Product Acceptability and Preference Questionnaire was completed by the subject at weeks 1 and 2 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. | Week 1, Week 2 | 
| Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product | Product Acceptability and Preference Questionnaire was completed by the subject at week 8 using the following scale: 1, very satisfied; 2, satisfied; 3, neutral; 4, unsatisfied; 5, very unsatisfied. | Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne vulgaris