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

Sponsor:	Galderma
Information provided by:	Galderma
ClinicalTrials.gov Identifier:	NCT00688064

Purpose

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.

Condition	Intervention	Phase
Severe Acne Vulgaris	Drug: Adapalene BPO Gel associated with Doxycyline Hyclate Drug: Vehicle Gel associated with Doxycycline Hyclate	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 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.

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium Benzoyl peroxide Adapalene

U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:

Percent change from Baseline in total lesion count at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]
Incidence of Adverse Events, Local tolerance worst-score post Baseline, Postinflammatory hyperpigmentation for subjects with phototypes IV to VI [ Time Frame: All along the study ] [ Designated as safety issue: Yes ]
Investigator Global Assessment at each post Baseline visit, Global Improvement from Baseline at week 12/early termination [ Time Frame: Weeks 2, 4, 8 and 12 ] [ Designated as safety issue: No ]

Enrollment:	459
Study Start Date:	August 2008
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel associated with Doxycyline Hyclate 100 mg tablet.	Drug: Adapalene BPO Gel associated with Doxycyline Hyclate Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.
2: Active Comparator Vehicle Gel associated with Doxycycline Hyclate 100 mg tablet	Drug: Vehicle Gel associated with Doxycycline Hyclate Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.

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

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

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00688064

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Locations

United States, California
Galderma Investigational Site
SAN DIEGO, California, United States
Galderma Investigational Site
OCEANSIDE, 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
HERSHEY, 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
HOUSTON, Texas, United States
Galderma Investigational Site
AUSTIN, Texas, United States
Galderma Investigational Site
ARLINGTON, Texas, United States
Galderma Investigational Site
LUBBOCK, Texas, United States
Galderma Investigational Site
College Station, 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:

Linda Stein Gold, MD

Henry Ford Medical Center-New Center One, Detroit, MI

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.29074
Study First Received:	May 28, 2008
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00688064 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
Anti-Infective Agents
Antiprotozoal Agents
Facial Dermatoses
Physiological Effects of Drugs
Benzoyl Peroxide
Adapalene
Sebaceous Gland Diseases
Acne Vulgaris
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Acneiform Eruptions

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Skin Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Doxycycline

ClinicalTrials.gov processed this record on November 27, 2009