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

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 Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (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 Cetaphil 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 ] [ Designated as safety issue: Yes ]
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


Ages Eligible for Study:	12 Years to 35 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided


Responsible Party:	Jean-Charles DHUIN Clinical Trial Manager, Galderma
ClinicalTrials.gov Identifier:	NCT00883233 History of Changes
Other Study ID Numbers:	RD.03.SPR.29085
Study First Received:	April 16, 2009
Results First Received:	October 11, 2010
Last Updated:	November 11, 2010
Health Authority:	Canada: Health Canada Canada: Ethics Review Committee

Keywords provided by Galderma:


Acne

Additional relevant MeSH terms:


Adapalene Benzoyl Peroxide Emollients Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antirheumatic Agents	Central Nervous System Agents Dermatologic Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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