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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00883233
First received: April 16, 2009
Last updated: November 11, 2010
Last verified: November 2010
  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:


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
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:
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:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Adapalene
Benzoyl Peroxide
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014