Treatment of Moderate to Severe Facial Acne Vulgaris
Information source: Warner Chilcott
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: doxycycline (Drug); doxycycline (Drug); doxycycline (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Warner Chilcott Official(s) and/or principal investigator(s):
Angelo Secci, MD, Study Director, Affiliation: Warner Chilcott
Overall contact:
Lara Cardinali, Phone: 973-442-3285, Email: lcardinali@wcrx.com
Summary
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.
Clinical Details
Official title: Phase 2 Study Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 3 Doses of Doxycycline as Compared to Placebo in the Treatment of Moderate to Severe Facial Acne Vulgaris
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Primary efficacy variables will be both the IGA and the absolute change from baseline for inflammatory lesions count at Week 12.
Secondary outcome: Secondary efficacy variables will be the percent change in inflammatory lesion count and the absolute change from baseline for non-inflammatory and total lesions count at Week 12.
Eligibility
Minimum age: 12 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Locations and Contacts
Lara Cardinali, Phone: 973-442-3285, Email: lcardinali@wcrx.com
Warner Chilcott Investigational Site, Fremont, California 94538, United States; Recruiting
Warner Chilcott Investigational Site, Sacramento, California 95816, United States; Recruiting
Warner Chilcott Investigational Site, Encino, California 91436, United States; Recruiting
Warner Chilcott Investigational Site, Los Angeles, California 90045, United States; Recruiting
Warner Chilcott Investigational Site, Denver, Colorado 80210, United States; Recruiting
Warner Chilcott Investigational Site, Miami, Florida 33175, United States; Recruiting
Warner Chilcott Investigational Site, Newnan, Georgia 30263, United States; Recruiting
Warner Chilcott Investigational Site, Snellville, Georgia 30078, United States; Recruiting
Warner Chilcott Investigational Site, Louisville, Kentucky 40217, United States; Recruiting
Warner Chilcott Investigational Site, Clinton Township, Michigan 48038, United States; Recruiting
Warner Chilcott Investigational Site, Albuquerque, New Mexico 87106-5239, United States; Recruiting
Warner Chilcott Investigational Site, Rochester, New York 14623, United States; Recruiting
Warner Chilcott Investigational Site, Winston Salem, North Carolina 27103, United States; Recruiting
Warner Chilcott Investigational Site, Cincinnati, Ohio 45219, United States; Recruiting
Warner Chilcott Investigational Site, Portland, Oregon 97210, United States; Recruiting
Warner Chilcott Investigational Site, Broomall, Pennsylvania 19008, United States; Recruiting
Warner Chilcott Investigational Site, Fort Washington, Pennsylvania 19034, United States; Recruiting
Warner Chilcott Investigational Site, Houston, Texas 77056, United States; Recruiting
Warner Chilcott Investigational Site, Austin, Texas 78759, United States; Recruiting
Warner Chilcott Investigational Site, San Antonio, Texas 78229, United States; Recruiting
Warner Chilcott Investigational Site, College Station, Texas 77845, United States; Recruiting
Warner Chilcott Investigational Site, Dallas, Texas 75246, United States; Recruiting
Warner Chilcott Investigational Site, Spokane, Washington 99204, United States; Recruiting
Additional Information
Starting date: February 2008
Last updated: July 22, 2008
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