Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

Study Overview
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Brief Summary
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Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Detailed Description
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The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks. Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Official Title
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A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Benzoyl peroxide gel
* Drug: Clindamycin gel
* Drug: Tazarotene cream
* Drug: Vehicle gel
* Drug: Vehicle cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Subjects must be males or females 12 to 45 years of age. Subjects must have acne on their face. Female subjects of childbearing potential must have a negative pregnancy test. If sexually active, one medically acceptable forms of contraception must be practiced from baseline to the last study visit. Subjects must have the ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study. Subjects must be capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements). Subjects must be able to complete the study and to comply with study instructions. Exclusion Criteria: Subjects who are pregnant, trying to become pregnant, or breast-feeding. Subjects with conditions that may influence the safety and or efficacy assessments of the study including, but not limited to: regional enteritis or inflammatory bowel disease, lupus, dermatomyositis, rosacea, seborrheic dermatitis, beard folliculitis, or perioral dermatitis, subject who are immunocompromised or have had any major illness within 30 days before the screening examination History of known or suspected intolerance including any known hypersensitivity or previous allergic reaction to any of the ingredients of the study products Subjects who have used topical antibiotics or topical steroids on the face, facial procedures, or any investigational therapy within the past 4 weeks or systemic retinoids within the past 6 months. Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put the subject at unacceptable risk for participation in the study. Other exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Benzoyl peroxide/clindamycin gel + tazarotene cream | Drug: Benzoyl peroxide gel<br>* 5% benzoyl peroxide in a gel applied topically once a day<br>Drug: Clindamycin gel<br>* 1% clindamycin phosphate applied topically once a day<br>Drug: Tazarotene cream<br>* 0.1 % tazarotene in a cream applied topically once a day<br>|
| Active Comparator: 2<br>Benzoyl peroxide/clindamycin gel + vehicle cream | Drug: Benzoyl peroxide gel<br>* 5% benzoyl peroxide in a gel applied topically once a day<br>Drug: Clindamycin gel<br>* 1% clindamycin phosphate applied topically once a day<br>Drug: Vehicle cream<br>* Vehicle cream is an identical cream without the active ingredients<br>|
| Active Comparator: 3<br>Benzoyl peroxide gel + tazarotene cream | Drug: Benzoyl peroxide gel<br>* 5% benzoyl peroxide in a gel applied topically once a day<br>Drug: Tazarotene cream<br>* 0.1 % tazarotene in a cream applied topically once a day<br>|
| Active Comparator: 4<br>Clindamycin gel + tazarotene cream | Drug: Clindamycin gel<br>* 1% clindamycin phosphate applied topically once a day<br>Drug: Tazarotene cream<br>* 0.1 % tazarotene in a cream applied topically once a day<br>|
| Active Comparator: 5<br>Vehicle gel+ tazarotene cream | Drug: Tazarotene cream<br>* 0.1 % tazarotene in a cream applied topically once a day<br>Drug: Vehicle gel<br>* Vehicle gel is an identical gel without the active ingredients<br>|
| Placebo Comparator: 6<br>Vehicle gel + vehicle cream | Drug: Vehicle gel<br>* Vehicle gel is an identical gel without the active ingredients<br>Drug: Vehicle cream<br>* Vehicle cream is an identical cream without the active ingredients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute Change in Lesion Counts (Total, Inflammatory, and Non-inflammatory) From Baseline to Week 12 | The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts [only post-Baseline]) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). | Baseline and up to Week 12 | 
| Proportion of Participants With a Minimum 2-grade Improvement in the Investigator's Static Global Assessment (ISGA) Score From Baseline to Week 12 | An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. | Baseline and up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline to Week 12 in Each of 3 Lesion Counts (Total, Inflammatory, and Non-inflammatory) | The investigator or designee took count of inflammatory lesions (papules, pustules, nodules and cysts) (ILC), noninflammatory lesions (open and closed comedones) (NILC) and total lesions (TLC) at Baseline, Weeks 2, 4, 8, and 12. Lesion counts were confined to the face. Each of 3 lesion counts (total, inflammatory and non-inflammatory) was analyzed using an analysis of covariance (ANCOVA) model with terms for treatment, center, Baseline value and treatment-by-center interaction. If the interaction was not significant at 0.1 level, this interaction was excluded in ANCOVA model. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified timepoints were analyzed (represented by n=X in the category titles). | Baseline and up to Week 12 | 
| Proportion of Participants With an ISGA Score of 0 or 1 at Week 12 | An ISGA was obtained at Baseline and at Weeks 2, 4, 8, and 12. The scores range from 0-5 (0=clear skin with no inflammatory or non-inflammatory lesions; 5=very severe with many non-inflammatory and inflammatory lesions and more than a few nodular lesions (may have cystic lesions). The higher score indicates more severe. The area considered for the ISGA was confined to the face. When possible, the same efficacy assessor performed all ISGA assessments on the same participant at all visits. Day 1 (Visit 1) was defined as Baseline. Only participants available at specified time points were analyzed. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne Vulgaris, Pimples, Acne