Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris

Status unconfirmed · Phase 2

Conditions studied: Acne Vulgaris

In brief

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.

Key facts

Study ID

NCT00098358

Run by

Critical Therapeutics

People needed

90

Starts

2004-11-01

Expected to finish

2005-05-01

Last updated by the study team

2007-02-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Therapeutics Clinical Research — San Diego, California, United States
• MedaPhase, Inc. — Newnan, Georgia, United States
• Dermatology Specialists, PSC — Louisville, Kentucky, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, 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
• Rivergate Dermatology — Goodlettsville, Tennessee, United States
• DermResearch, Inc. — Austin, Texas, United States
• J&S Studies, Inc. — Bryan, Texas, United States
• Virginia Clinical Research, Inc. — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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