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

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00098358
• Other study ID #: CTI-02-C04-201
• Status: Active, not recruiting
• Phase: Phase 2
• First received: December 7, 2004
• Last updated: February 5, 2007
• Start date: November 2004
• Est. completion date: May 2005

Study information

• Verified date: February 2007
• Source: Critical Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Zileuton

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	SUNY Downstate Medical Center	Brooklyn	New York
United States	J&S Studies, Inc.	Bryan	Texas
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Rivergate Dermatology	Goodlettsville	Tennessee
United States	Milton S. Hersey Medical Center	Hersey	Pennsylvania
United States	Dermatology Specialists, PSC	Louisville	Kentucky
United States	MedaPhase, Inc.	Newnan	Georgia
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Dermatology Associates of Rochester	Rochester	New York
United States	Therapeutics Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Critical Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of inflammatory lesions
Secondary	Physician's global assessment scale
Secondary	Change in number of non-inflammatory lesions
Secondary	Change in total numbers of lesions
Secondary	Change in sebum production