Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Michigan
• Collaborator: Novartis Pharmaceuticals
• Treatments: Lactitol; Pimecrolimus; Tacrolimus

Criteria

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