Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Phase 4TerminatedNCT00810862

Children's Hospital of Michigan18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

pimecrolimus active creamDRUG

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

placebo base creamOTHER

apply to affected study area twice daily for 21 days

Eligibility

Sex: ALLMin age: 2 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

modified IGA score

Time frame: 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

Data from ClinicalTrials.gov

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