Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810862

Enrollment

Registered

2008-12-18

Start date

2006-11-30

Completion date

2008-06-30

Last updated

2008-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

African American children

Brief summary

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

Interventions

DRUGpimecrolimus active cream

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

OTHERplacebo base cream

apply to affected study area twice daily for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026