Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications

Acne Vulgaris Clinical Trial

Official title: Two-week Study to Determine and Compare the Tolerance and Irritation Potential of Duac® Topical Gel (Clindamycin 1% and Benzoyl Peroxide 5%) to ACANYA™ Gel (Clindamycin Phosphate 1.2% and Benzoyl Peroxide 2.5%) Topical Acne Medications

Status Completed

Clinical Trial Summary

This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.

Clinical Trial Description

This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) and the other side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each product.

The eligible subjects (screened 3 days prior to randomization) who qualify will be entered into a 2-week treatment phase. The once-daily applications for the clindamycin and benzoyl peroxide 5%and clindamycin phosphate and benzoyl peroxide 2.5%) will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card.

A blinded expert grader will rate comparative product tolerance in terms of erythema and dryness on each week day (excluding Saturdays and Sundays) during the study before study product is applied.

Instruments will be used to measure transepidermal water loss (TEWL) to assess skin moisture in order to evaluate product mildness. Instrumentation measurements of skin surface conductance will be utilized to evaluate product performance in terms of level of skin hydration.

Subjects will complete questionnaires and all adverse events will be recorded. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

• NCT number: NCT01015638
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 4
• Start date: August 2009
• Completion date: September 2009