Adapalene-BPO Gel in the Treatment of Acne Vulgaris as a 6-Month Maintenance

Condition(s) targeted: Acne

Intervention: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel (Drug); Vehicle Gel (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Diane Thiboutot, MD, Principal Investigator, Affiliation: Penn State College of Medicine, Hershey, PA

Overall contact:
Jean-Charles Dhuin, BSc, Phone: 33-4-9295-2921, Email: jean-charles.dhuin@galderma.com

The purpose of this study is to demonstrate the efficacy of Adapalene 0. 1% /Benzoyl Peroxide 2. 5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

Official title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-Month Acne Maintenance Treatment

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Maintenance rate for total lesions at Week 24 : defined as the percentage of subjects maintaining at least 50% of the improvement obtained with prior combination therapy, in terms of total lesion counts.

Secondary outcome:

Maintenance rate for total lesions: at each intermediate visits, Maintenance rate for inflammatory lesions: at each post Baseline visit, Maintenance rate for non-inflammatory lesions: at each post Baseline visit

Incidence of Adverse Events, Local tolerance Worst-score post Baseline, Postinflammatory Hyperpigmentation Worst-score post Baseline.

Detailed description:

This study is a follow-up to RD. 03. SPR. 29074 - ACCESS I - "Adapalene-BPO Gel Associated With

Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects who completed the previous study (RD. 03. SPR29074)and had obtained at least a

good Improvement (Grade, 0, 1, 2 or 3)

Exclusion Criteria:

- Female Subjects who are pregnant, nursing or planning a pregnancy during the study

- Subjects who foresee intensive UV exposure during the study (mountain sports, UV

radiation, sunbathing, etc).

Jean-Charles Dhuin, BSc, Phone: 33-4-9295-2921, Email: jean-charles.dhuin@galderma.com

Galderma Investigational Site, CAROLINA, Puerto Rico; Recruiting

Galderma Investigational Site, Aibonito, Puerto Rico; Recruiting

Galderma Investigational Site, SAN DIEGO, California, United States; Recruiting

Galderma Investigational Site, OCEANSIDE, California, United States; Recruiting

Galderma Investigational Site, LONGMONT, Colorado, United States; Recruiting

Galderma Investigational Site, DENVER, Colorado, United States; Recruiting

Galderma Investigational Site, MIAMI, Florida, United States; Recruiting

Galderma Investigational Site, SNELLVILLE, Georgia, United States; Recruiting

Galderma Investigational Site, CHICAGO, Illinois, United States; Recruiting

Galderma Investigational Site, EVANSVILLE, Indiana, United States; Recruiting

Galderma Investigational Site, OVERLAND PARK, Kansas, United States; Recruiting

Galderma Investigational Site, LOUISVILLE, Kentucky, United States; Recruiting

Galderma Investigational Site, Fort Gariot, Michigan, United States; Recruiting

Galderma Investigational Site, DETROIT, Michigan, United States; Recruiting

Galderma Investigational Site, FRIDLEY, Minnesota, United States; Recruiting

Galderma Investigational Site, OMAHA, Nebraska, United States; Recruiting

Galderma Investigational Site, ALBUQUERQUE, New Mexico, United States; Recruiting

Galderma Investigational Site, STONY BROOK, New York, United States; Recruiting

Galderma Investigational Site, Winston Salem, North Carolina, United States; Recruiting

Galderma Investigational Site, Warren, Ohio, United States; Recruiting

Galderma Investigational Site, CINCINNATI, Ohio, United States; Withdrawn

Galderma Investigational Site, BARRIE, Ontario, Canada; Recruiting

Galderma Investigational Site, NORTH BAY, Ontario, Canada; Recruiting

Galderma Investigational Site, WINDSOR, Ontario, Canada; Recruiting

Galderma Investigational Site, Hazleton, Pennsylvania, United States; Recruiting

Galderma Investigational Site, HERSEY, Pennsylvania, United States; Recruiting

Galderma Investigational Site, QUEBEC CITY, Quebec, Canada; Recruiting

Galderma Investigational Site, SIMPSONVILLE, South Carolina, United States; Recruiting

Galderma Investigational Site, San Antonio, Texas, United States; Recruiting

Galderma Investigational Site, LUBBOCK, Texas, United States; Recruiting

Galderma Investigational Site, AUSTIN, Texas, United States; Recruiting

Galderma Investigational Site, COLLEGE STATION, Texas, United States; Recruiting

Galderma Investigational Site, ARLINGTON, Texas, United States; Recruiting

Galderma Investigational Site, HOUSTON, Texas, United States; Recruiting

Galderma Investigational Site, webster, Texas 77598, United States; Recruiting

Starting date: October 2008
Ending date: August 2009
Last updated: October 24, 2008