Clinical trial NCT00687908: Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne
Keywords: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 243
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 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.

Detailed description: This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - "Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris"

Eligibility criteria: Inclusion Criteria:

* Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)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).

Primary outcomes:
measure: Maintenance Success for Total Lesions at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Maintenance Success for Inflamatory Lesions at Week 24
timeFrame: Week 24
measure: Maintenance Success for Non-inflammatory Lesions at Week 24
timeFrame: Week 24
measure: Investigator Global Assessment (IGA) Maintenance Success at Week 24
timeFrame: Baseline, Week 24
measure: Percent of Subjects With Adverse Events
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Galderma Investigational Site
state: California
city: Denver
country: United States
facility: Galderma Investigational Site
state: Colorado
city: Longmont
country: United States
facility: Galderma Investigational Site
state: Colorado
city: Miami
country: United States
facility: Galderma Investigational Site
state: Florida
city: Snellville
country: United States
facility: Galderma Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Galderma Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Galderma Investigational Site
state: Indiana
city: Overland Park
country: United States
facility: Galderma Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Galderma Investigational Site
state: Kentucky
city: Detroit
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Fort Gratiot
country: United States
facility: Galderma Investigational Site
state: Michigan
city: Fridley
country: United States
facility: Galderma Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Galderma Investigational Site
state: Nebraska
city: Albuquerque
country: United States
facility: Galderma Investigational Site
state: New Mexico
city: Stony Brook
country: United States
facility: Galderma Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Galderma Investigational Site
state: North Carolina
city: Warren
country: United States
facility: Galderma Investigational Site
state: Ohio
city: Hazleton
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Galderma Investigational Site
state: Pennsylvania
city: Simpsonville
country: United States
facility: Galderma Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: Galderma Investigational Site
state: Texas
city: Austin
country: United States
facility: Galderma Investigational Site
state: Texas
city: College Station
country: United States
facility: Galderma Investigational Site
state: Texas
city: Houston
country: United States
facility: Galderma Investigational Site
state: Texas
city: Lubbock
country: United States
facility: Galderma Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Galderma Investigational Site
state: Texas
city: Webster
country: United States
facility: Galderma Investigational Site
state: Texas
city: Barrie
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: North Bay
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Galderma Investigational Site
state: Ontario
city: Quebec City
country: Canada
facility: Galderma Investigational Site
state: Quebec
city: Aibonito
country: Puerto Rico
facility: Galderma Investigational Site
city: Carolina
country: Puerto Rico
facility: Galderma Investigational Site
Study officials:
affiliation: Penn State College of Medicine, Hershey, PA
name: Diane Thiboutot, MD
role: PRINCIPAL_INVESTIGATOR
References: