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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00883233

First Posted: April 17, 2009

Last Update Posted: December 8, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Galderma

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

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.


Enrollment:	123
Study Start Date:	April 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00883233

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site


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 Submitted:	April 16, 2009
First Posted:	April 17, 2009
Results First Submitted:	October 11, 2010
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

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