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

Critical Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Zileuton

Study type: Interventional

Funder types: Industry

Identifiers

NCT00098358

CTI-02-C04-201

Details and patient eligibility

About

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.

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind