Status:
TERMINATED
Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children
Lead Sponsor:
Children's Hospital of Michigan
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2-17 years
Phase:
PHASE4
Brief Summary
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.
Eligibility Criteria
Inclusion
- African American children aged 2 to 17 years
- mild to moderate atopic dermatitis
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00810862
Start Date
November 1 2006
End Date
June 1 2008
Last Update
December 18 2008
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