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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-01

Study Completion Date

2009-06-05

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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CTGel plus BPO wash

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

Group Type EXPERIMENTAL

CTGel/ BPO Wash

Intervention Type DRUG

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.

CTGel

Soap Free Cleanser in the morning and CTGel in the evening

Group Type ACTIVE_COMPARATOR

Soap Free Cleanser and CTGel

Intervention Type DRUG

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.

Interventions

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CTGel/ BPO Wash

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.

Intervention Type DRUG

Soap Free Cleanser and CTGel

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.

Intervention Type DRUG

Other Intervention Names

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Veltin Veltin

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.