Viewing Study NCT00098358



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Last Modification Date: 2024-10-26 @ 9:11 AM
Study NCT ID: NCT00098358
Status: UNKNOWN
Last Update Posted: 2007-02-07
First Post: 2004-12-07

Brief Title: Study of Oral Zileuton in the Treatment of Moderate to Severe Facial Acne Vulgaris
Sponsor: Critical Therapeutics
Organization: Critical Therapeutics

Study Overview

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
Status: UNKNOWN
Status Verified Date: 2007-02
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None