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

NCT00098358 | Unknown Phase 2

• 1 other identifier: CTI-02-C04-201
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Acne Vulgaris

Keywords

Leukotrienes; inflammation

Outcome Measures

Primary Outcomes (1)

• Change in number of inflammatory lesions

Secondary Outcomes (4)

• Physician's global assessment scale

• Change in number of non-inflammatory lesions

• Change in total numbers of lesions

• Change in sebum production

Interventions

Zileuton DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe facial acne vulgaris
• to 60 facial inflammatory lesions
• to 200 facial non-inflammatory lesions
• No more than 3 facial nodular cystic lesions

You may not qualify if:

• 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

Sponsors & Collaborators

• Critical Therapeutics: lead

Study Sites (12)

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

MedaPhase, Inc.

Newnan, Georgia, 30263, United States

Location

Dermatology Specialists, PSC

Louisville, Kentucky, 40202, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

Milton S. Hersey Medical Center

Hersey, Pennsylvania, 17033-0850, United States

Location

Rivergate Dermatology

Goodlettsville, Tennessee, 37072, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J&S Studies, Inc.

Bryan, Texas, 77802, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Related 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. doi: 10.1001/archderm.139.5.668. No abstract available.

  PMID: 12756111 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris; Inflammation

Interventions

zileuton

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Walter Newman, Ph.D.

  Critical Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2004
• First Posted: December 8, 2004
• Study Start: November 1, 2004
• Study Completion: May 1, 2005
• Last Updated: February 7, 2007

Record last verified: 2007-02

Locations

US (12)