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

• Status: Unknown status
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Critical Therapeutics
• Treatments: Hydroxyurea; Zileuton

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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