Status:
UNKNOWN
Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
Lead Sponsor:
Critical Therapeutics
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00098358
Start Date
November 1 2004
End Date
May 1 2005
Last Update
February 7 2007
Active Locations (12)
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1
Therapeutics Clinical Research
San Diego, California, United States, 92123
2
MedaPhase, Inc.
Newnan, Georgia, United States, 30263
3
Dermatology Specialists, PSC
Louisville, Kentucky, United States, 40202
4
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432