Clinical trial NCT00098358: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acne Vulgaris
Keywords: Leukotrienes
inflammation
Lead sponsor: Critical Therapeutics
Sponsor class: INDUSTRY
First posted: 2004-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in number of inflammatory lesions
Secondary outcomes:
measure: Physician's global assessment scale
measure: Change in number of non-inflammatory lesions
measure: Change in total numbers of lesions
measure: Change in sebum production
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Newnan
country: United States
facility: MedaPhase, Inc.
state: Georgia
city: Louisville
country: United States
facility: Dermatology Specialists, PSC
state: Kentucky
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Rochester
country: United States
facility: Dermatology Associates of Rochester
state: New York
city: Hersey
country: United States
facility: Milton S. Hersey Medical Center
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Rivergate Dermatology
state: Tennessee
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Bryan
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Critical Therapeutics
name: Walter Newman, Ph.D.
role: STUDY_DIRECTOR
References:
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.