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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Critical Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Critical Therapeutics
ClinicalTrials.gov Identifier:
NCT00098358
First received: December 7, 2004
Last updated: February 5, 2007
Last verified: February 2007
  Purpose

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.


Condition Intervention Phase
Acne Vulgaris
Drug: Zileuton
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Critical Therapeutics:

Primary Outcome Measures:
  • Change in number of inflammatory lesions

Secondary Outcome Measures:
  • Physician's global assessment scale
  • Change in number of non-inflammatory lesions
  • Change in total numbers of lesions
  • Change in sebum production

Estimated Enrollment: 90
Study Start Date: November 2004
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098358

Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Georgia
MedaPhase, Inc.
Newnan, Georgia, United States, 30263
United States, Kentucky
Dermatology Specialists, PSC
Louisville, Kentucky, United States, 40202
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Pennsylvania
Milton S. Hersey Medical Center
Hersey, Pennsylvania, United States, 17033-0850
United States, Tennessee
Rivergate Dermatology
Goodlettsville, Tennessee, United States, 37072
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J&S Studies, Inc.
Bryan, Texas, United States, 77802
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Critical Therapeutics
Investigators
Study Director: Walter Newman, Ph.D. Critical Therapeutics
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00098358     History of Changes
Other Study ID Numbers: CTI-02-C04-201
Study First Received: December 7, 2004
Last Updated: February 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Critical Therapeutics:
Leukotrienes
inflammation

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Zileuton
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Lipoxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014