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

This study is currently recruiting patients.

Sponsored by: Critical Therapeutics
Information provided by: 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.

Condition Treatment or Intervention Phase
Acne Vulgaris
 Drug: Zileuton
Phase II

MedlinePlus related topics:  Acne

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
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
Expected Total Enrollment:  90

Study start: November 2004;  Expected completion: July 2005
Last follow-up: May 2005;  Data entry closure: June 2005


Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  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 fuction 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

Location and Contact Information

      Therapeutics Clinical Research, San Diego,  California,  92123,  United States; No longer recruiting

      MedaPhase, Inc., Newnan,  Georgia,  30263,  United States; No longer recruiting

      Dermatology Specialists, PSC, Louisville,  Kentucky,  40202,  United States; No longer recruiting

      Minnesota Clinical Study Center, Fridley,  Minnesota,  55432,  United States; No longer recruiting

New Mexico
      Academic Dermatology Associates, Albuquerque,  New Mexico,  87106,  United States; No longer recruiting

New York
      Dermatology Associates of Rochester, Rochester,  New York,  14623,  United States; No longer recruiting

      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
Wei-Li Lee  718-270-1229 
Alan Shalita,  Principal Investigator

      Milton S. Hersey Medical Center, Hersey,  Pennsylvania,  17033-0850,  United States; Recruiting
Silvia Gosik  717-531-1513 
Diane Thiboutot,  Principal Investigator

      Rivergate Dermatology, Goodlettsville,  Tennessee,  37072,  United States; No longer recruiting

      DermResearch, Inc., Austin,  Texas,  78759,  United States; No longer recruiting

      J&S Studies, Inc., Bryan,  Texas,  77802,  United States; No longer recruiting

      Virginia Clinical Research, Inc., Norfolk,  Virginia,  23507,  United States; No longer recruiting

More Information


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. No abstract available.

Study ID Numbers:  CTI-02-C04-201
Record last reviewed:  December 2004
Last Updated:  January 28, 2005
Record first received:  December 7, 2004 Identifier:  NCT00098358
Health Authority: United States: Food and Drug Administration processed this record on 2005-04-08

Cache Date: April 9, 2005