GoldBamboo.com - Knowledge is strong medicine
  

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


  Not Signed In - Sign In / Register




General Topics A-Z

Facial Treatments

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

This study is currently recruiting patients.

Sponsored by: Critical Therapeutics
Information provided by: Critical Therapeutics

Purpose

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.

Condition Treatment or Intervention Phase
Acne Vulgaris
  Drug: Zileuton
 Phase II

MedlinePlus related topics:  Acne

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Change in number of inflammatory lesions
Secondary Outcomes: Physician's global assessment scale; Change in number of non-inflammatory lesions; Change in total numbers of lesions; Change in sebum production
Expected Total Enrollment:  90

Study start: November 2004;  Expected completion: July 2005
Last follow-up: May 2005;  Data entry closure: June 2005

Eligibility

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

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 fuction 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

Location and Contact Information


California
      Therapeutics Clinical Research, San Diego,  California,  92123,  United States; No longer recruiting

Georgia
      MedaPhase, Inc., Newnan,  Georgia,  30263,  United States; No longer recruiting

Kentucky
      Dermatology Specialists, PSC, Louisville,  Kentucky,  40202,  United States; No longer recruiting

Minnesota
      Minnesota Clinical Study Center, Fridley,  Minnesota,  55432,  United States; No longer recruiting

New Mexico
      Academic Dermatology Associates, Albuquerque,  New Mexico,  87106,  United States; No longer recruiting

New York
      Dermatology Associates of Rochester, Rochester,  New York,  14623,  United States; No longer recruiting

      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States; Recruiting
Wei-Li Lee  718-270-1229    wei-li.lee@downstate.edu 
Alan Shalita,  Principal Investigator

Pennsylvania
      Milton S. Hersey Medical Center, Hersey,  Pennsylvania,  17033-0850,  United States; Recruiting
Silvia Gosik  717-531-1513    sgosik@psu.edu 
Diane Thiboutot,  Principal Investigator

Tennessee
      Rivergate Dermatology, Goodlettsville,  Tennessee,  37072,  United States; No longer recruiting

Texas
      DermResearch, Inc., Austin,  Texas,  78759,  United States; No longer recruiting

      J&S Studies, Inc., Bryan,  Texas,  77802,  United States; No longer recruiting

Virginia
      Virginia Clinical Research, Inc., Norfolk,  Virginia,  23507,  United States; No longer recruiting

More Information

Publications

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. No abstract available.

Study ID Numbers:  CTI-02-C04-201
Record last reviewed:  December 2004
Last Updated:  January 28, 2005
Record first received:  December 7, 2004
ClinicalTrials.gov Identifier:  NCT00098358
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Facial Treatments.

October 7, 2008


Page Updated: October 3, 2005
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Massachusetts Law | Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.