Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

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

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

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: pimecrolimus active cream; Other: placebo base cream

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pimecrolimus; Pimecrolimus 1% cream	Drug: pimecrolimus active cream; Pimecrolimus 1% cream apply to affected study area twice daily for 21 days; Other Names: Elidel 1% cream Novartis Pharmaceuticals
PLACEBO_COMPARATOR: 2; Placebo cream over affected study area	Other: placebo base cream; apply to affected study area twice daily for 21 days; Other Names: Elidel base cream without active agent; by Novartis Pharmaceuticals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Michigan
• Collaborators: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): June 1, 2008

Study Registration Dates

• First Submitted: December 17, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (ESTIMATE): December 18, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 18, 2008
• Last Update Submitted That Met QC Criteria: December 17, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: African American children
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Cathartics; Calcineurin Inhibitors; Pimecrolimus; Lactitol
• Other Study ID Numbers: pimecrolimus1