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

February 5, 2007 updated by: Critical Therapeutics

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
    • Georgia
      • Newnan, Georgia, United States, 30263
        • MedaPhase, Inc.
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists, PSC
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Rochester, New York, United States, 14623
        • Dermatology Associates of Rochester
    • Pennsylvania
      • Hersey, Pennsylvania, United States, 17033-0850
        • Milton S. Hersey Medical Center
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Bryan, Texas, United States, 77802
        • J&S Studies, Inc.
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in number of inflammatory lesions

Secondary Outcome Measures

Outcome Measure
Physician's global assessment scale
Change in number of non-inflammatory lesions
Change in total numbers of lesions
Change in sebum production

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Critical Therapeutics

Investigators

  • Study Director: Walter Newman, Ph.D., Critical Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

December 7, 2004

First Submitted That Met QC Criteria

December 7, 2004

First Posted (ESTIMATE)

December 8, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

February 7, 2007

Last Update Submitted That Met QC Criteria

February 5, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI-02-C04-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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