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

NCT ID: NCT00106496

Last Updated: 2014-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

410 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-07-31

Brief Summary

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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

Detailed Description

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

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1A

Group Type EXPERIMENTAL

Protopic

Intervention Type DRUG

topical

1B

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

topical

2

Open label

Group Type EXPERIMENTAL

Protopic

Intervention Type DRUG

topical

3A

Group Type EXPERIMENTAL

Protopic

Intervention Type DRUG

topical

3B

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

topical

4

Open label

Group Type EXPERIMENTAL

Protopic

Intervention Type DRUG

topical

Interventions

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Protopic

topical

Intervention Type DRUG

Corticosteroid

topical

Intervention Type DRUG

placebo

topical

Intervention Type DRUG

Other Intervention Names

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tacrolimus ointment FK506 ointment

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Investigational Site

Birmingham, Alabama, United States

Site Status

Investigational Site

Irvine, California, United States

Site Status

Investigational Site

Loma Linda, California, United States

Site Status

Investigational Site

San Diego, California, United States

Site Status

New Haven, Connecticut, United States

Site Status

Miami, Florida, United States

Site Status

Investigational Site

Atlanta, Georgia, United States

Site Status

Investigational Site

Chicago, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Investigational Site

Chicago, Illinois, United States

Site Status

Lexington, Kentucky, United States

Site Status

Baltimore, Maryland, United States

Site Status

Investigational Site

Ann Arbor, Michigan, United States

Site Status

Investigational Site

Detroit, Michigan, United States

Site Status

Investigational Site

St Louis, Missouri, United States

Site Status

Investigational Site

Lebanon, New Hampshire, United States

Site Status

Investigational Site

New York, New York, United States

Site Status

Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Investigational Site

Cincinnati, Ohio, United States

Site Status

Investigational Site

Portland, Oregon, United States

Site Status

Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Investigational Site

Nashville, Tennessee, United States

Site Status

Investigational Site

Dallas, Texas, United States

Site Status

Investigational Site

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18359127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19015204 (View on PubMed)

Other Identifiers

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20-04-002

Identifier Type: -

Identifier Source: org_study_id

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