Condition(s) treated: Acne Vulgaris

Intervention: doxycycline (Drug); doxycycline (Drug); doxycycline (Drug); Placebo (Drug)

Phase: Phase 2

Enrollment status: Recruiting

Sponsor: Warner Chilcott

Principal investigator(s) or official(s):
Angelo Secci, MD, Study Director, Affiliation: Warner Chilcott

Overall contact:
Lara Cardinali, Phone: 973-442-3285, Email: lcardinali@wcrx.com

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.

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. (Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84)

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. (Time Frame: Evaluations will be made at days 0, 7, 14, 42, 56, 70, 84)

Minimum eligible age: 12 Years. Maximum eligible age: 45 Years. Eligible 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.

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, 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, 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, United States; Recruiting

Warner Chilcott Investigational Site, Dallas, Texas 75246, United States; Not yet recruiting

Warner Chilcott Investigational Site, Spokane, Washington 99204, United States; Recruiting

Start date: February 2008
Last updated: June 3, 2008

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