Adapalene-BPO Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance - Full Text View

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00687908

Purpose

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.

Condition	Intervention	Phase
Acne	Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Drug: Vehicle Gel	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

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. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: Weeks 4, 8, 12, 16, 20 and 24 ] [ Designated as safety issue: No ]
Incidence of Adverse Events, Local tolerance Worst-score post Baseline, Postinflammatory Hyperpigmentation Worst-score post Baseline. [ Time Frame: All along the study ] [ Designated as safety issue: Yes ]

Enrollment:	244
Study Start Date:	November 2008
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel	Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Topical Gel to the face, once daily in the evening for 24 weeks.
2: Placebo Comparator Vehicle Gel	Drug: Vehicle Gel Topical Gel to the face, once daily in the evening for 24 weeks.

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"

Eligibility

Ages Eligible for Study:	12 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687908

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Locations

United States, California
Galderma Investigational Site
SAN DIEGO, California, United States
United States, Colorado
Galderma Investigational Site
LONGMONT, Colorado, United States
Galderma Investigational Site
DENVER, Colorado, United States
United States, Florida
Galderma Investigational Site
MIAMI, Florida, United States
United States, Georgia
Galderma Investigational Site
SNELLVILLE, Georgia, United States
United States, Illinois
Galderma Investigational Site
CHICAGO, Illinois, United States
United States, Indiana
Galderma Investigational Site
EVANSVILLE, Indiana, United States
United States, Kansas
Galderma Investigational Site
OVERLAND PARK, Kansas, United States
United States, Kentucky
Galderma Investigational Site
LOUISVILLE, Kentucky, United States
United States, Michigan
Galderma Investigational Site
Fort Gratiot, Michigan, United States
Galderma Investigational Site
DETROIT, Michigan, United States
United States, Minnesota
Galderma Investigational Site
FRIDLEY, Minnesota, United States
United States, Nebraska
Galderma Investigational Site
OMAHA, Nebraska, United States
United States, New Mexico
Galderma Investigational Site
ALBUQUERQUE, New Mexico, United States
United States, New York
Galderma Investigational Site
STONY BROOK, New York, United States
United States, North Carolina
Galderma Investigational Site
Winston Salem, North Carolina, United States
United States, Ohio
Galderma Investigational Site
Warren, Ohio, United States
United States, Pennsylvania
Galderma Investigational Site
Hazleton, Pennsylvania, United States
Galderma Investigational Site
HERSEY, Pennsylvania, United States
United States, South Carolina
Galderma Investigational Site
SIMPSONVILLE, South Carolina, United States
United States, Texas
Galderma Investigational Site
San Antonio, Texas, United States
Galderma Investigational Site
ARLINGTON, Texas, United States
Galderma Investigational Site
AUSTIN, Texas, United States
Galderma Investigational Site
COLLEGE STATION, Texas, United States
Galderma Investigational Site
LUBBOCK, Texas, United States
Galderma Investigational Site
HOUSTON, Texas, United States
Galderma Investigational Site
webster, Texas, United States, 77598
Canada, Ontario
Galderma Investigational Site
BARRIE, Ontario, Canada
Galderma Investigational Site
NORTH BAY, Ontario, Canada
Galderma Investigational Site
WINDSOR, Ontario, Canada
Canada, Quebec
Galderma Investigational Site
QUEBEC CITY, Quebec, Canada
Puerto Rico
Galderma Investigational Site
CAROLINA, Puerto Rico
Galderma Investigational Site
Aibonito, Puerto Rico

Sponsors and Collaborators

Galderma

Investigators

Principal Investigator:

Diane Thiboutot, MD

Penn State College of Medicine, Hershey, PA

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Galderma ( Jean-Charles DHUIN Clinical Trial Manager )
Study ID Numbers:	RD.03.SPR.29075
Study First Received:	May 28, 2008
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00687908 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board; Canada: Health Canada; Canada: Ethics Review Committee

Keywords provided by Galderma:

Acne

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Facial Dermatoses
Skin Diseases
Physiological Effects of Drugs
Benzoyl Peroxide
Sebaceous Gland Diseases
Adapalene
Acne Vulgaris
Pharmacologic Actions
Sensory System Agents

Acneiform Eruptions
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 22, 2009