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

Completed · Phase 3

Conditions studied: Severe Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT00688064

Run by

Galderma R&D

People needed

459

Starts

2008-08-01

Expected to finish

2009-02-01

Last updated by the study team

2021-02-18

Who can join

Age: 12 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Subjects with more than 3 nodules or cysts on the face,
• Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Where it is running

• 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 — Hazleton, Pennsylvania, United States
• Galderma Investigational Site — Hershey, Pennsylvania, United States
• 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

Full record on ClinicalTrials.gov

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