Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00810862
• Other study ID #: pimecrolimus1
• Status: Terminated
• Phase: Phase 4
• First received: December 17, 2008
• Last updated: December 17, 2008
• Start date: November 2006
• Est. completion date: June 2008

Study information

• Verified date: December 2008
• Source: Children's Hospital of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• pimecrolimus active cream
Pimecrolimus 1% cream apply to affected study area twice daily for 21 days

Other:
• placebo base cream
apply to affected study area twice daily for 21 days

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Michigan	Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	modified IGA score		at baseline, one week and three weeks following initiation of therapy	No
Secondary	hypopigmentation scale score		baseline, one and three weeks following initiation of treatment	Yes