This trial is active, not recruiting.

Condition acne vulgaris
Treatment zileuton
Phase phase 2
Sponsor Critical Therapeutics
Start date November 2004
End date May 2005
Trial size 90 participants
Trial identifier NCT00098358, CTI-02-C04-201


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Primary Outcomes

Change in number of inflammatory lesions
time frame:

Secondary Outcomes

Physician's global assessment scale
time frame:
Change in number of non-inflammatory lesions
time frame:
Change in total numbers of lesions
time frame:
Change in sebum production
time frame:

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in February 2007.
Information provided to ClinicalTrials.gov by Critical Therapeutics.