Trial | NCT00098358  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    zileuton ...

  • Study Participants

    90
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.
Study Started
Nov 30
2004
Study Completion
May 31
2005
Last Update
Feb 07
2007
Estimate

Drug Zileuton

Criteria 

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
No Results Posted