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

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
CTGel plus BPO wash	CTGel/ BPO Wash	Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening
CTGel	Soap Free Cleanser and CTGel	Soap Free Cleanser in the morning and CTGel in the evening

Primary Outcome Measures

Name	Time	Method
Local Tolerability - Skin Dryness	Week 4	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
Local Tolerability - Skin Scaling	Week 4	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
Local Tolerability - Erythema (Redness)	Week 4	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

Secondary Outcome Measures

Name	Time	Method
Subject Assessment of Burning/Stinging	Week 4	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
Subject Assessment of Itching	Week 4	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

Locations (5): The Skin Wellness Center, PC
🇺🇸
Knoxville, Tennessee, United States
Dermatology Associates Research
🇺🇸
Coral Gables, Florida, United States
Dermatology Consulting Services
🇺🇸
High Point, North Carolina, United States
Premier Clinical Research
🇺🇸
Spokane, Washington, United States
Grekin Skin Institute
🇺🇸
Warren, Michigan, United States