Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

Condition(s) targeted: Severe Acne Vulgaris

Intervention: Adapalene BPO Gel associated with Doxycyline Hyclate (Drug); Vehicle Gel associated with Doxycycline Hyclate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Linda Stein Gold, MD, Principal Investigator, Affiliation: Henry Ford Medical Center-New Center One, Detroit, MI

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

The purpose of this study is to demonstrate the efficacy of Adapalene 0. 1% / Benzoyl Peroxide 2. 5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0. 1% /Benzoyl Peroxide 2. 5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Official title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.

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

Primary outcome: Percent change from Baseline in total lesion count at Week 12

Secondary outcome:

Percent change from Baseline in total lesion count at each intermediate visit, Percent change in inflammatory lesion count and in non-inflammatory lesion count at each post Baseline visit.

Incidence of Adverse Events, Local tolerance worst-score post Baseline, Postinflammatory hyperpigmentation for subjects with phototypes IV to VI

Investigator Global Assessment at each post Baseline visit, Global Improvement from Baseline at week 12/early termination

Detailed description: Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR. 29075)

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

Criteria:

Inclusion Criteria:

- Male or female Subjects of any race, aged 12 to 35 years inclusive

- Subjects with severe facial acne (global severity score of 4)

- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,

excluding the nose

- Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open

comedones and closed comedones) on the face, excluding the nose

Exclusion Criteria:

- Subjects with more than 3 nodules or cysts on the face,

- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced

acne, etc.)

Jean-Charles DHUIN, BSc, Phone: 33-4-9295-2921, Email: jean-charles.dhuin@galerma.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 Gratiot, 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, HERSHEY, 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, ARLINGTON, Texas, United States; Recruiting

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

Galderma Investigational Site, College Station, Texas, United States; Recruiting

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

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