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

Information source: Galderma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Severe Acne Vulgaris

Intervention: Adapalene BPO Gel associated with Doxycyline Hyclate (Drug); Vehicle Gel associated with Doxycycline Hyclate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma

Official(s) and/or principal investigator(s):
Linda Stein Gold, MD, Principal Investigator, Affiliation: Henry Ford Medical Center-New Center One, Detroit, MI

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percent Change From Baseline in Total Lesion Counts at Week 12.

Secondary outcome:

Percent Change From Baseline in Inflammatory Lesion Counts at Week 12.

Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12

Success Rate on the Investigator's Global Assessment

Percent of Subjects With Adverse Events

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

Minimum age: 12 Years. Maximum age: 35 Years. Gender(s): Both.

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.)

Locations and Contacts

Galderma Investigational Site, Aibonito, Puerto Rico

Galderma Investigational Site, Carolina, Puerto Rico

Galderma Investigational Site, Oceanside, California, United States

Galderma Investigational Site, San Diego, California, United States

Galderma Investigational Site, Denver, Colorado, United States

Galderma Investigational Site, Longmont, Colorado, United States

Galderma Investigational Site, Miami, Florida, United States

Galderma Investigational Site, Snellville, Georgia, United States

Galderma Investigational Site, Chicago, Illinois, United States

Galderma Investigational Site, Evansville, Indiana, United States

Galderma Investigational Site, Overland Park, Kansas, United States

Galderma Investigational Site, Louisville, Kentucky, United States

Galderma Investigational Site, Detroit, Michigan, United States

Galderma Investigational Site, Fort Gratiot, Michigan, United States

Galderma Investigational Site, Fridley, Minnesota, United States

Galderma Investigational Site, Omaha, Nebraska, United States

Galderma Investigational Site, Albuquerque, New Mexico, United States

Galderma Investigational Site, Stony Brook, New York, United States

Galderma Investigational Site, Winston Salem, North Carolina, United States

Galderma Investigational Site, Warren, Ohio, United States

Galderma Investigational Site, Barrie, Ontario, Canada

Galderma Investigational Site, North Bay, Ontario, Canada

Galderma Investigational Site, Windsor, Ontario, Canada

Galderma Investigational Site, Hazleton, Pennsylvania, United States

Galderma Investigational Site, Hershey, Pennsylvania, United States

Galderma Investigational Site, Quebec city, Quebec, Canada

Galderma Investigational Site, Simpsonville, South Carolina, 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, Houston, Texas, United States

Galderma Investigational Site, Lubbock, Texas, United States

Galderma Investigational Site, San Antonio, Texas, United States

Galderma Investigational Site, Webster, Texas 77598, United States

Additional Information

Starting date: August 2008
Last updated: March 31, 2010

Page last updated: August 23, 2015

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