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NCT00883233 Clinical Trial

Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris

Acne Clinical Trial

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Official title:
Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00883233
Other study ID # RD.03.SPR.29085
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2009
Est. completion date September 2009

Study information
Verified date November 2010
Source Galderma R&D
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 12 Years to 35 Years
Eligibility Inclusion Criteria: - Male or female Subjects of any race, aged 12 to 35 years inclusive - Subjects with mild or moderate facial acne vulgaris - Subjects with skin phototype I to IV Exclusion Criteria: - Subjects with more than 1 nodules or cysts on the face, - Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Adapalene BPO Gel standard daily overnight application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
• Adapalene-BPO 3-hour daily application before bedtime
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
• Adapalene-BPO Gel every other day application
Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
• Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion
Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks

Locations
Country Name City State
Canada Galderma Investigational Site Montreal Quebec
Canada Galderma Investigational Site Windsor Ontario

Sponsors (1)
Lead Sponsor Collaborator
Galderma R&D

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit. Week 4
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