Treatment of Moderate to Severe Facial Acne Vulgaris

• ClinicalTrials.gov Identifier: NCT00612573
• Recruitment Status: Completed
• First Posted: February 11, 2008
• Results First Posted: April 19, 2011
• Last Update Posted: April 22, 2013
• Sponsor: Warner Chilcott
• Information provided by (Responsible Party): Warner Chilcott

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: Doxycycline 0.6 mg/kg/day; Drug: Doxycycline 1.2 mg/kg/day; Drug: Doxycycline 2.4 mg/kg/day; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 257 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: February 2008
• Actual Primary Completion Date: November 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Doxycyline 0.6 mg/kg/day; Doxycycline dosed at 40 mg/day to subjects of appropriate weights	Drug: Doxycycline 0.6 mg/kg/day; doxycycline 40 mg/day, oral, 12 weeks
Experimental: Doxycycline 1.2 mg/kg/day; Doxycycline dosed at 80 mg/day to subjects of appropriate weights	Drug: Doxycycline 1.2 mg/kg/day; doxycycline 80 mg/day, 12 weeks
Experimental: Doxycycline 2.4 mg/kg/day; Doxycycline dosed at 160 mg/day to subjects of appropriate weights	Drug: Doxycycline 2.4 mg/kg/day; doxycycline 160 mg/day, 12 weeks
Placebo Comparator: Placebo	Drug: Placebo; Placebo, 12 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage Patients With Successful Outcome Investigator's Global Assessment (IGA) Score at Week 12, Intent to Treat (ITT) Population [ Time Frame: Week 12 ]
   IGA: 0/clear (clear skin no lesions, inflammatory or non-inflammatory), 1/almost clear (rare non-inflammatory lesion w/no more than 1 small inflammatory lesion), 2/mild (some non-inflammatory lesions with no more than a few inflammatory lesions, papules/pustules only, no nodular lesions), 3/moderate (up to many non-inflammatory lesions, some inflammatory lesions, no more than 1 small nodular lesion), 4/severe (many non-inflammatory & inflammatory lesions, no more than a few nodular lesions. Lower score improvement in score. Success=IGA decrease of at least 2 grades from baseline score.
2. Absolute Change in Inflammatory Lesion Count From Baseline to Week 12, ITT Population [ Time Frame: Baseline to Week 12 ]
   Change derived as Baseline evaluation minus the Week 12 evaluation. Thus a positive change reflects a reduction in lesion count. Inflammatory Lesion Count includes nodules, papules and pustules.

Secondary Outcome Measures :

1. Absolute Change From Baseline to Week 12 in NonInflammatory Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]
   Noninflammatory Lesion Count includes open and closed comedones.
2. Absolute Change From Baseline to Week 12 in Total Lesion Count, ITT Population [ Time Frame: Baseline to Week 12 ]
   Total Lesion Count is the sum of inflammatory and noninflammatory lesions.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 45 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, California

Warner Chilcott Investigational Site

Encino, California, United States, 91436

Warner Chilcott Investigational Site

Fremont, California, United States, 94538

Warner Chilcott Investigational Site

Los Angeles, California, United States, 90045

Warner Chilcott Investigational Site

Sacramento, California, United States, 95816

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

Austin, Texas, United States, 78759

Warner Chilcott Investigational Site

College Station, Texas, United States, 77845

Warner Chilcott Investigational Site

Dallas, Texas, United States, 75246

Warner Chilcott Investigational Site

Houston, Texas, United States, 77056

Warner Chilcott Investigational Site

San Antonio, Texas, United States, 78229

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

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT00612573
• Other Study ID Numbers: PR-07907; WC2055
• First Posted: February 11, 2008
• Results First Posted: April 19, 2011
• Last Update Posted: April 22, 2013
• Last Verified: April 2013

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Doxycycline; Anti-Bacterial Agents; Anti-Infective Agents; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents