Treatment of Moderate to Severe Facial Acne Vulgaris - Full Text View

Sponsor:	Warner Chilcott
Information provided by:	Warner Chilcott
ClinicalTrials.gov Identifier:	NCT00612573

Purpose

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.

Condition	Intervention	Phase
Acne Vulgaris	Drug: doxycycline Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Acne

Drug Information available for: Doxycycline Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Enrollment:	257
Study Start Date:	February 2008
Study Completion Date:	December 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: doxycycline doxycycline 40 mg/day, oral
2: Experimental	Drug: doxycycline doxycycline 80 mg/day
3: Experimental	Drug: doxycycline doxycycline 160 mg/day
4: Placebo Comparator	Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612573

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Locations

United States, California
Warner Chilcott Investigational Site
Fremont, California, United States, 94538
Warner Chilcott Investigational Site
Sacramento, California, United States, 95816
Warner Chilcott Investigational Site
Encino, California, United States, 91436
Warner Chilcott Investigational Site
Los Angeles, California, United States, 90045
United States, Colorado
Warner Chilcott Investigational Site
Denver, Colorado, United States, 80210
United States, Florida
Warner Chilcott Investigational Site
Miami, Florida, United States, 33175
United States, Georgia
Warner Chilcott Investigational Site
Newnan, Georgia, United States, 30263
Warner Chilcott Investigational Site
Snellville, Georgia, United States, 30078
United States, Kentucky
Warner Chilcott Investigational Site
Louisville, Kentucky, United States, 40217
United States, Michigan
Warner Chilcott Investigational Site
Clinton Township, Michigan, United States, 48038
United States, New Mexico
Warner Chilcott Investigational Site
Albuquerque, New Mexico, United States, 87106-5239
United States, New York
Warner Chilcott Investigational Site
Rochester, New York, United States, 14623
United States, North Carolina
Warner Chilcott Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Warner Chilcott Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Oregon
Warner Chilcott Investigational Site
Portland, Oregon, United States, 97210
United States, Pennsylvania
Warner Chilcott Investigational Site
Broomall, Pennsylvania, United States, 19008
Warner Chilcott Investigational Site
Fort Washington, Pennsylvania, United States, 19034
United States, Texas
Warner Chilcott Investigational Site
Houston, Texas, United States, 77056
Warner Chilcott Investigational Site
Austin, Texas, United States, 78759
Warner Chilcott Investigational Site
San Antonio, Texas, United States, 78229
Warner Chilcott Investigational Site
College Station, Texas, United States, 77845
Warner Chilcott Investigational Site
Dallas, Texas, United States, 75246
United States, Washington
Warner Chilcott Investigational Site
Spokane, Washington, United States, 99204

Sponsors and Collaborators

Warner Chilcott

Investigators

Study Director:

Angelo Secci, MD

Warner Chilcott

More Information

No publications provided

Responsible Party:	Warner Chilcott ( Dr. Angelo Secci )
Study ID Numbers:	PR-07907, WC2055
Study First Received:	January 25, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00612573 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Antiprotozoal Agents
Facial Dermatoses
Skin Diseases
Sebaceous Gland Diseases
Acne Vulgaris
Pharmacologic Actions

Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Acneiform Eruptions
Therapeutic Uses
Doxycycline

ClinicalTrials.gov processed this record on November 27, 2009