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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Zileuton

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No