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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Acne	Drug: Adapalene BPO Gel standard daily overnight application; Drug: Adapalene-BPO 3-hour daily application before bedtime; Drug: Adapalene-BPO Gel every other day application; Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	123 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
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
Study Start Date :	April 2009
Actual Primary Completion Date :	September 2009
Actual Study Completion Date :	September 2009

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; 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	Drug: 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; Other Name: 3-hour before bedtime
Experimental: 2; 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	Drug: 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; Other Name: every other day
Experimental: 3; 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	Drug: 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; Other Name: Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion
Active Comparator: 4; Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week	Drug: Adapalene BPO Gel standard daily overnight application; Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week; Other Name: Standard

Outcome Measures

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Primary Outcome Measures :

1. Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. [ Time Frame: Week 4 ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	12 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.)

Contacts and Locations

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Locations

Canada, Ontario
Galderma Investigational Site
Windsor, Ontario, Canada
Canada, Quebec
Galderma Investigational Site
Montreal, Quebec, Canada

Sponsors and Collaborators

Galderma

Investigators

Principal Investigator:	Jerry Tan, MD	Windsor, ON, Canada

More Information

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Additional Information:

Related Info 

Responsible Party:	Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier:	NCT00883233 History of Changes
Other Study ID Numbers:	RD.03.SPR.29085
First Posted:	April 17, 2009
Results First Posted:	December 8, 2010
Last Update Posted:	December 8, 2010
Last Verified:	November 2010

Keywords provided by Galderma:

Acne

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Benzoyl Peroxide; Adapalene; Dermatologic Agents; Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents