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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098358
Recruitment Status : Unknown
Verified February 2007 by Critical Therapeutics.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2004
Last Update Posted : February 7, 2007
Information provided by:
Critical Therapeutics

December 7, 2004
December 8, 2004
February 7, 2007
November 2004
Not Provided
Change in number of inflammatory lesions
Same as current
Complete list of historical versions of study NCT00098358 on Archive Site
  • Physician's global assessment scale
  • Change in number of non-inflammatory lesions
  • Change in total numbers of lesions
  • Change in sebum production
Same as current
Not Provided
Not Provided
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
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Acne Vulgaris
Drug: Zileuton
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
May 2005
Not Provided

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
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Critical Therapeutics
Not Provided
Study Director: Walter Newman, Ph.D. Critical Therapeutics
Critical Therapeutics
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP