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

Stiefel

Status and phase: Completed; Phase 3

Conditions: Acne Vulgaris

Treatments: Drug: Soap Free Cleanser and CTGel; Drug: CTGel/ BPO Wash

Study type: Interventional

Funder types: Industry

Identifiers

NCT00891982

114679

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

CTGel plus BPO wash

Experimental group

Description:

Benzoyl peroxide (BPO) Wash in the morning and CTGel in the evening

Treatment:

Drug: CTGel/ BPO Wash

CTGel

Active Comparator group

Description:

Soap Free Cleanser in the morning and CTGel in the evening

Treatment:

Drug: Soap Free Cleanser and CTGel