Treatment of Moderate to Severe Facial Acne Vulgaris

Completed · Phase 2 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

Randomized, multi-center, double-blind, placebo-controlled 12-week study to assess the safety and efficacy of 3 doses of an oral formulation of Doxycycline oral tablets using the Investigator's Global Assessment (IGA) score and the absolute change from baseline in inflammatory lesion count in patients with moderate to severe facial acne vulgaris. Additionally, the absolute change from baseline in non-inflammatory and total lesions of the active study medication to placebo will be evaluated.

Key facts

Study ID

NCT00612573

Run by

Warner Chilcott

People needed

257

Starts

2008-02-01

Expected to finish

2008-12-01

Last updated by the study team

2013-04-22

Who can join

Age: 12 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be between 12 and 45 years of age.
• Has a diagnosis of moderate to severe facial acne vulgaris with no more than two nodules on the face

You may not qualify if…

• Is allergic to tetracycline-class antibiotics or to any ingredient in the study medication.
• Has a history of pseudomembranous colitis or antibiotic-associated colitis.
• Has a history of hepatitis or liver damage or renal impairment.

Where it is running

• Warner Chilcott Investigational Site — Encino, California, United States
• Warner Chilcott Investigational Site — Fremont, California, United States
• Warner Chilcott Investigational Site — Los Angeles, California, United States
• Warner Chilcott Investigational Site — Sacramento, California, United States
• Warner Chilcott Investigational Site — Denver, Colorado, United States
• Warner Chilcott Investigational Site — Miami, Florida, United States
• Warner Chilcott Investigational Site — Newnan, Georgia, United States
• Warner Chilcott Investigational Site — Snellville, Georgia, United States
• Warner Chilcott Investigational Site — Louisville, Kentucky, United States
• Warner Chilcott Investigational Site — Clinton Township, Michigan, United States
• Warner Chilcott Investigational Site — Albuquerque, New Mexico, United States
• Warner Chilcott Investigational Site — Rochester, New York, United States
• Warner Chilcott Investigational Site — Winston-Salem, North Carolina, United States
• Warner Chilcott Investigational Site — Cincinnati, Ohio, United States
• Warner Chilcott Investigational Site — Portland, Oregon, United States
• Warner Chilcott Investigational Site — Broomall, Pennsylvania, United States
• Warner Chilcott Investigational Site — Fort Washington, Pennsylvania, United States
• Warner Chilcott Investigational Site — Austin, Texas, United States
• Warner Chilcott Investigational Site — College Station, Texas, United States
• Warner Chilcott Investigational Site — Dallas, Texas, United States
• Warner Chilcott Investigational Site — Houston, Texas, United States
• Warner Chilcott Investigational Site — San Antonio, Texas, United States
• Warner Chilcott Investigational Site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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