Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

December 17, 2008 updated by: Children's Hospital of Michigan

A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pimecrolimus
Pimecrolimus 1% cream
Drug: pimecrolimus active cream
Pimecrolimus 1% cream apply to affected study area twice daily for 21 days
Other Names:
  • Elidel 1% cream Novartis Pharmaceuticals
PLACEBO_COMPARATOR: 2
Placebo cream over affected study area
Other: placebo base cream
apply to affected study area twice daily for 21 days
Other Names:
  • Elidel base cream without active agent
  • by Novartis Pharmaceuticals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis
Time Frame: at baseline, one week and three weeks following treatment initiation
at baseline, one week and three weeks following treatment initiation

Secondary Outcome Measures

Outcome Measure
Time Frame
modified IGA score
Time Frame: at baseline, one week and three weeks following initiation of therapy
at baseline, one week and three weeks following initiation of therapy
hypopigmentation scale score
Time Frame: baseline, one and three weeks following initiation of treatment
baseline, one and three weeks following initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Michigan

Collaborators

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

June 1, 2008

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

December 17, 2008

First Submitted That Met QC Criteria

December 17, 2008

First Posted (ESTIMATE)

December 18, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2008

Last Update Submitted That Met QC Criteria

December 17, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pimecrolimus1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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