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Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

NCT ID: NCT00810862

Last Updated: 2008-12-18

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-06-30

Brief Summary

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Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.

Detailed Description

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Conditions

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Atopic Dermatitis

Keywords

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African American children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pimecrolimus

Pimecrolimus 1% cream

Group Type EXPERIMENTAL

pimecrolimus active cream

Intervention Type DRUG

Pimecrolimus 1% cream apply to affected study area twice daily for 21 days

2

Placebo cream over affected study area

Group Type PLACEBO_COMPARATOR

placebo base cream

Intervention Type OTHER

apply to affected study area twice daily for 21 days

Interventions

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pimecrolimus active cream

Pimecrolimus 1% cream apply to affected study area twice daily for 21 days

Intervention Type DRUG

placebo base cream

apply to affected study area twice daily for 21 days

Intervention Type OTHER

Other Intervention Names

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Elidel 1% cream Novartis Pharmaceuticals Elidel base cream without active agent by Novartis Pharmaceuticals

Eligibility Criteria

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Inclusion Criteria

* African American children aged 2 to 17 years
* mild to moderate atopic dermatitis

Exclusion Criteria

* m-EASI less than 3 at baseline
* allergy to Elidel or components
* use of oral steroids, immunosuppressive agents,cytostatics of phototherapy within 4 weeks prior to study.
* previous continuous or non-continuous use of pimecrolimus or tacrolimus for greater than 11 months within 2 weeks of enrollment.
* active skin infections.
* immunocompromised patients.
* previous history of skin cancer or lymphoma
* any hypopigmentation in study areas
* pregnant or breastfeeding
* participation in another investigational trial
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Children's Hospital of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Children's Hospital of Michigan

Other Identifiers

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pimecrolimus1

Identifier Type: -

Identifier Source: org_study_id