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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
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.
Dermatology Associates Research
Coral Gables, Florida, United States
Grekin Skin Institute
Warren, Michigan, United States
Dermatology Consulting Services
High Point, North Carolina, United States
The Skin Wellness Center, PC
Knoxville, Tennessee, United States
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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
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Premier Clinical Research
Spokane, Washington, United States
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: Week 4
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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: 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 1. \- Trace 2. \- Mild 3. \- Moderate 4. \- Marked 5. \- Severe
Time frame: Week 4