Clinical trial NCT00441415: Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Official title: Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-02-28
Enrollment: 272
Sex: ALL
Minimum age (years): 12
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.


Eligibility criteria: Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with acne vulgaris, meeting specific inclusion/exclusion criteria.

Main inclusion criteria:

1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
3. Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.

Main exclusion criteria:

1. Subjects with acne cystic lesions,
2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).

Primary outcomes:
measure: Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
Secondary outcomes:
measure: Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
measure: Global severity assessment at each post Baseline visit
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Paul YAMAUCHI
state: California
city: Fridley
country: United States
facility: Steven E. KEMPERS
state: Minnesota
city: Albuquerque
country: United States
facility: Dr Alicia BUCKO
state: New Mexico
city: Rochester
country: United States
facility: Elisabeth ARTHUR
state: New York
Study officials:
affiliation: Helendale Dermatology - Rochester NY - 585-266-5420
name: Elisabeth ARTHUR, MD
affiliation: Academic Dermatology Associates - Albuquerque NM - 505-247-4220
name: Alicia BUCKO, MD
affiliation: Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887
name: Paul YAMAUCHI, MD
affiliation: Minnesota Clinical Study Center - Fridley MN - 763-571-4200
name: Steven E. KEMPERS, MD
affiliation: Otto-von-Guericke University - Magdeburg - Germany
name: Harald GOLLNICK, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitatsklinikum - Lubeck - Germany
name: Yvonne FRAMBACH, MD
affiliation: Dresden University - Dresden - Germany
name: Michael MEURER, MD
affiliation: Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany
name: Christos ZOUBOULIS, MD
affiliation: Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany
name: Roland KAUFMANN, MD
affiliation: Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany
name: Thomas SCHWARZ, MD
References: