Clinical trial NCT00688064: Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Acne Vulgaris
Keywords: Acne
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2008-06-02
Enrollment: 459
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 (quoted as BPO) 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.

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)

Eligibility 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.)

Primary outcomes:
measure: Percent Change From Baseline in Total Lesion Counts at Week 12.
timeFrame: Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.
timeFrame: Week 12
measure: Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12
timeFrame: Week 12
measure: Success Rate on the Investigator's Global Assessment
timeFrame: Week 12
measure: Percent of Subjects With Adverse Events
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Galderma Investigational Site
state: California
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: Henry Ford Medical Center-New Center One, Detroit, MI
name: Linda Stein Gold, MD
role: PRINCIPAL_INVESTIGATOR
References: