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NCT00106496 Clinical Trial

A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00106496
Other study ID # 20-04-002
Secondary ID
Status Completed
Phase Phase 4
First received March 25, 2005
Last updated September 17, 2014
Start date October 2004
Est. completion date July 2006

Study information
Verified date September 2014
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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 to placebo in the long-term management of Atopic Dermatitis

Description:

Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.

Recruitment information / eligibility
Status Completed
Enrollment 410
Est. completion date July 2006
Est. primary completion date July 2006
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Protopic
topical
• Corticosteroid
topical
• placebo
topical

Locations
Country Name City State
United States Investigational Site Ann Arbor Michigan
United States Investigational Site Atlanta Georgia
United States Investigational Site Birmingham Alabama
United States Investigational Site Chicago Illinois
United States Investigational Site Chicago Illinois
United States Investigational Site Cincinnati Ohio
United States Investigational Site Dallas Texas
United States Investigational Site Dallas Texas
United States Investigational Site Detroit Michigan
United States Investigational Site Irvine California
United States Investigational Site Lebanon New Hampshire
United States Investigational Site Loma Linda California
United States Investigational Site Nashville Tennessee
United States Investigational Site New York New York
United States Investigational Site Philadelphia Pennsylvania
United States Investigational Site Portland Oregon
United States Investigational Site San Diego California
United States Investigational Site St. Louis Missouri
United States Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & Publications (2)

Breneman D, Fleischer AB Jr, Abramovits W, Zeichner J, Gold MH, Kirsner RS, Shull TF, Crowe AW, Jaracz E, Hanifin JM; Tacrolimus Ointment Study Group. Intermittent therapy for flare prevention and long-term disease control in stabilized atopic dermatitis: a randomized comparison of 3-times-weekly applications of tacrolimus ointment versus vehicle. J Am Acad Dermatol. 2008 Jun;58(6):990-9. doi: 10.1016/j.jaad.2008.02.008. Epub 2008 Mar 21. — View Citation

Paller AS, Eichenfield LF, Kirsner RS, Shull T, Jaracz E, Simpson EL; US Tacrolimus Ointment Study Group. Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. Pediatrics. 2008 Dec;122(6):e1210-8. doi: 10.1542/peds.2008-1343. Epub 2008 Nov 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment 2 weeks No
Secondary Percentage of patients reporting cutaneous adverse events overall Day 4 through end of study No
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Completed NCT02637206 - Skin Irritation Study of GSK2894512 Cream Phase 1
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