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

Primary Purpose

Acne Vulgaris

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zileuton
Sponsored by
Critical Therapeutics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring Leukotrienes, inflammation

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Therapeutics Clinical Research
  • MedaPhase, Inc.
  • Dermatology Specialists, PSC
  • Minnesota Clinical Study Center
  • Academic Dermatology Associates
  • SUNY Downstate Medical Center
  • Dermatology Associates of Rochester
  • Milton S. Hersey Medical Center
  • Rivergate Dermatology
  • DermResearch, Inc.
  • J&S Studies, Inc.
  • Virginia Clinical Research, Inc.

Outcomes

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

Full Information

First Posted
December 7, 2004
Last Updated
February 5, 2007
Sponsor
Critical Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT00098358
Brief Title
Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Critical Therapeutics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Leukotrienes, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zileuton
Primary Outcome Measure Information:
Title
Change in number of inflammatory lesions
Secondary Outcome Measure Information:
Title
Physician's global assessment scale
Title
Change in number of non-inflammatory lesions
Title
Change in total numbers of lesions
Title
Change in sebum production

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Newman, Ph.D.
Organizational Affiliation
Critical Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Dermatology Specialists, PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
SUNY Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Dermatology Associates of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Milton S. Hersey Medical Center
City
Hersey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Rivergate Dermatology
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc.
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12756111
Citation
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.
Results Reference
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Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris

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