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

Critical Therapeutics90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acne Vulgaris

Interventions

ZileutonDRUG

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (12)

Therapeutics Clinical Research

San Diego, California, United States

MedaPhase, Inc.

Newnan, Georgia, United States

Dermatology Specialists, PSC

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Change in number of inflammatory lesions

Secondary Outcomes

Physician's global assessment scale

Change in number of non-inflammatory lesions

Change in total numbers of lesions

Change in sebum production

Data from ClinicalTrials.gov

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