Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
Phase 4
Terminated
- Conditions
- Atopic Dermatitis
- Interventions
- Other: placebo base cream
- Registration Number
- NCT00810862
- Lead Sponsor
- Children's Hospital of Michigan
- Brief Summary
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 18
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pimecrolimus pimecrolimus active cream Pimecrolimus 1% cream 2 placebo base cream Placebo cream over affected study area
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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