Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Children's Hospital of Michigan

Status and phase: Terminated; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: pimecrolimus active cream; Other: placebo base cream

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00810862

pimecrolimus1

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

Pimecrolimus

Experimental group

Description:

Pimecrolimus 1% cream

Treatment:

Drug: pimecrolimus active cream

2

Placebo Comparator group

Description:

Placebo cream over affected study area

Treatment:

Other: placebo base cream