Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
- Conditions
- Acne Vulgaris
- Registration Number
- NCT00098358
- Lead Sponsor
- Critical Therapeutics
- Brief Summary
Tissue inflammation is a major component of the acne disease process. Leukotriene B4 (LTB4) is thought to be a major player in the development of tissue inflammation. Synthesis of LTB4 is controlled by the enzyme 5-lipoxygenase. Zileuton blocks the activity of 5-lipoxygenase. This study will test the safety and efficacy of zileuton in the treatment of facial acne.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
- Moderate to severe facial acne vulgaris
- 20 to 60 facial inflammatory lesions
- 10 to 200 facial non-inflammatory lesions
- No more than 3 facial nodular cystic lesions
- Uncontrolled systemic disease
- Use of systemic or topical acne therapy within 14 days of study
- Use of systemic retinoids within past 2 years
- Skin diseases that interfere with acne counts
- Active liver disease
- Screening elevations in liver function tests
- Positive serology for hepatitis B or C
- Use of theophylline, warfarin, or propranolol within 7 days of study
- Use of Singulair or Accolate within 14 days of study
- Female patients who are pregnant or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in number of inflammatory lesions
- Secondary Outcome Measures
Name Time Method Physician's global assessment scale Change in number of non-inflammatory lesions Change in total numbers of lesions Change in sebum production
Trial Locations
- Locations (12)
Rivergate Dermatology
🇺🇸Goodlettsville, Tennessee, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Dermatology Associates of Rochester
🇺🇸Rochester, New York, United States
Milton S. Hersey Medical Center
🇺🇸Hersey, Pennsylvania, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
Dermatology Specialists, PSC
🇺🇸Louisville, Kentucky, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
J&S Studies, Inc.
🇺🇸Bryan, Texas, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States