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

Information source: Critical Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acne Vulgaris

Intervention: Zileuton (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Critical Therapeutics

Official(s) and/or principal investigator(s):
Walter Newman, Ph.D., Study Director, Affiliation: Critical Therapeutics


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: Change in number of inflammatory lesions

Secondary outcome:

Physician's global assessment scale

Change in number of non-inflammatory lesions

Change in total numbers of lesions

Change in sebum production


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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 and Contacts

Therapeutics Clinical Research, San Diego, California 92123, United States

MedaPhase, Inc., Newnan, Georgia 30263, United States

Dermatology Specialists, PSC, Louisville, Kentucky 40202, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Academic Dermatology Associates, Albuquerque, New Mexico 87106, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Dermatology Associates of Rochester, Rochester, New York 14623, United States

Milton S. Hersey Medical Center, Hersey, Pennsylvania 17033-0850, United States

Rivergate Dermatology, Goodlettsville, Tennessee 37072, United States

DermResearch, Inc., Austin, Texas 78759, United States

J&S Studies, Inc., Bryan, Texas 77802, United States

Virginia Clinical Research, Inc., Norfolk, Virginia 23507, United States

Additional Information

Related publications:

Zouboulis CC, Nestoris S, Adler YD, Orth M, Orfanos CE, Picardo M, Camera E, Cunliffe WJ. A new concept for acne therapy: a pilot study with zileuton, an oral 5-lipoxygenase inhibitor. Arch Dermatol. 2003 May;139(5):668-70.

Starting date: November 2004
Last updated: February 5, 2007

Page last updated: August 23, 2015

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