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

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Clinical Proof of Concept Study of Zileuton IR in Patients With Moderate to Severe Facial Acne Vulgaris

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00098358

Enrollment

Registered

2004-12-08

Start date

2004-11-30

Completion date

2005-05-31

Last updated

2007-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Keywords

Leukotrienes, inflammation

Brief 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.

Interventions

DRUGZileuton

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in number of inflammatory lesions	—

Secondary

Measure	Time frame
Physician's global assessment scale	—
Change in number of non-inflammatory lesions	—
Change in total numbers of lesions	—
Change in sebum production	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026