Not Signed In -
Tioconazole Vaginal Ointment |
Monistat 1; Vagistat-1 |
Clinical Trial: A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients with Atopic Dermatitis
This study is currently recruiting patients.
|
Purpose
The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment and vehicle (ointment base without the active drug) in the long-term management of Atopic Dermatitis.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Dermatitis, Atopic | Drug: topical tacrolimus (Protopic Ointment) | Phase IV |
MedlinePlus related topics: Allergy; Dermatitis; Genetic Disorders; Skin Diseases
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis
Secondary Outcomes: The secondary outcome is the percentage of patients reporting cutaneous adverse events overall
Expected Total Enrollment: 400
Study start: October 2004; Expected completion: April 2007
Last follow-up: April 2006; Data entry closure: October 2006
Eligibility
Ages Eligible for Study: 2 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Patient must have Atopic Dermatitis
- Patient must be at least 2 years of age
Exclusion Criteria:
- Patient is pregnant or breast feeding an infant
Location and Contact Information
Alabama
Investigational Site, Birmingham, Alabama, 35205, United States; Recruiting
California
Investigational Site, Irvine, California, 92697, United States; Recruiting
Investigational Site, San Diego, California, 92123, United States; Recruiting
Investigational Site, Loma Linda, California, 92354, United States; Recruiting
Georgia
Investigational Site, Atlanta, Georgia, 30322, United States; Recruiting
Illinois
Investigational Site, Chicago, Illinois, 60611, United States; Recruiting
Investigational Site, Chicago, Illinois, 60614, United States; Recruiting
Michigan
Investigational Site, Ann Arbor, Michigan, 48109, United States; Recruiting
Investigational Site, Detroit, Michigan, 48202, United States; Recruiting
Missouri
Investigational Site, St. Louis, Missouri, 63110, United States; Recruiting
New Hampshire
Investigational Site, Lebanon, New Hampshire, 03756, United States; Recruiting
New York
Investigational Site, New York, New York, 10029, United States; Recruiting
North Carolina
Investigational Site, Winston Salem, North Carolina, 27157, United States; Recruiting
Ohio
Investigational Site, Cincinnati, Ohio, 45219, United States; Recruiting
Oregon
Investigational Site, Portland, Oregon, 97201, United States; Recruiting
Pennsylvania
Investigational Site, Philadelphia, Pennsylvania, 19115, United States; Recruiting
Tennessee
Investigational Site, Nashville, Tennessee, 37215, United States; Recruiting
Texas
Investigational Site, Dallas, Texas, 75390, United States; Recruiting
Investigational Site, Dallas, Texas, 75230, United States; Recruiting
More Information
Record last reviewed: March 2005
Last Updated: March 28, 2005
Record first received: March 25, 2005
ClinicalTrials.gov Identifier: NCT00106496
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
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