A Clinical Study to Evaluate the Tolerability of a Topical Antibiotic and Retinoid Used in a Combined Regimen With a BPO Wash

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the tolerability of a combined regimen of a topical antibiotic and retinoid and a benzoyl peroxide wash.

Official Title
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A Phase 3B, Multicenter, Assessor-Blinded Study of the Tolerability of Clindamycin 1%-Tretinoin 0.025% Gel Used in Conjunction With Benzoyl Peroxide 4% Wash in Subjects With Mild to Moderate Facial Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CTGel/ BPO Wash
* Drug: Soap Free Cleanser and CTGel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with mild to moderate facial acne vulgaris, with no history of known or suspected hypersensitivity or previous allergic reaction to any of the ingredients of the study products (eg, topical antibiotics, retinoids or benzoyl peroxide), capable of understanding and willing to provide signed and dated written voluntary informed consent and able to complete the study and to comply with study instructions. Female subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study. Exclusion Criteria: Use of topical antibiotics on the face within the past 2 weeks or use of systemic antibiotics within the past 4 weeks.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTGel plus BPO wash<br>Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening | Drug: CTGel/ BPO Wash<br>* Benzoyl Peroxide (BPO) wash will be used once daily in the morning for 28 days Clindamycin and Tretinoin (CT) gel will be used once daily in the evening for 28 days.<br>* Other names: Veltin;|
| Active Comparator: CTGel<br>Soap Free Cleanser in the morning and CTGel in the evening | Drug: Soap Free Cleanser and CTGel<br>* Soap Free Cleanser will be used once daily in the morning for 28 days Clindamycin and Tretinoin gel will be used once daily in the evening for 28 days.<br>* Other names: Veltin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Tolerability - Skin Dryness | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Screening/baseline | 
| Local Tolerability - Skin Dryness | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 1 | 
| Local Tolerability - Skin Dryness | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 2 | 
| Local Tolerability - Skin Dryness | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 4 | 
| Local Tolerability - Skin Scaling | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Screening/baseline | 
| Local Tolerability - Skin Scaling | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 1 | 
| Local Tolerability - Skin Scaling | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 2 | 
| Local Tolerability - Skin Scaling | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 4 | 
| Local Tolerability - Erythema (Redness) | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Screening/baseline | 
| Local Tolerability - Erythema (Redness) | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 1 | 
| Local Tolerability - Erythema (Redness) | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 2 | 
| Local Tolerability - Erythema (Redness) | Local tolerability and irritation potential based on investigator assessments of dryness, scaling, and erythema in the areas of study product application. Grading will use the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Assessment of Burning/Stinging | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Screening/baseline | 
| Subject Assessment of Burning/Stinging | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 1 | 
| Subject Assessment of Burning/Stinging | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 2 | 
| Subject Assessment of Burning/Stinging | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 4 | 
| Subject Assessment of Itching | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Screening/Baseline | 
| Subject Assessment of Itching | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 1 | 
| Subject Assessment of Itching | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 2 | 
| Subject Assessment of Itching | Each symptom will be graded by the subject based upon the subject's impression during the previous week using the following scale: 0 - None - Trace - Mild - Moderate - Marked - Severe | Week 4 | 

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