Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
Public ClinicalTrials.gov record NCT00098358. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00098358
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2004
- Primary completion
- Not listed
- Completion
- Apr 30, 2005
- Last update posted
- Feb 6, 2007
2004 – 2005
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Therapeutics Clinical Research | San Diego | California | 92123 | — |
| MedaPhase, Inc. | Newnan | Georgia | 30263 | — |
| Dermatology Specialists, PSC | Louisville | Kentucky | 40202 | — |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | — |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | — |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | — |
| Dermatology Associates of Rochester | Rochester | New York | 14623 | — |
| Milton S. Hersey Medical Center | Hersey | Pennsylvania | 17033-0850 | — |
| Rivergate Dermatology | Goodlettsville | Tennessee | 37072 | — |
| DermResearch, Inc. | Austin | Texas | 78759 | — |
| J&S Studies, Inc. | Bryan | Texas | 77802 | — |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00098358, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 6, 2007 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00098358 live on ClinicalTrials.gov.