Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children - Full Text View

Sponsors and Collaborators:	Children's Hospital of Michigan Novartis Pharmaceuticals
Information provided by:	Children's Hospital of Michigan
ClinicalTrials.gov Identifier:	NCT00810862

Purpose

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

Condition	Intervention	Phase
Atopic Dermatitis	Drug: pimecrolimus active cream Other: placebo base cream	Phase IV

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A 3-Week, Single-Blind, Placebo-Controlled, Within-Patient, Randomized Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

Further study details as provided by Children's Hospital of Michigan:

Primary Outcome Measures:

Mean change in modified Modified EASI score a dermatologic evaluation of response to topical therapy for atopic dermatitis [ Time Frame: at baseline, one week and three weeks following treatment initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

modified IGA score [ Time Frame: at baseline, one week and three weeks following initiation of therapy ] [ Designated as safety issue: No ]
hypopigmentation scale score [ Time Frame: baseline, one and three weeks following initiation of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	November 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Pimecrolimus: Experimental Pimecrolimus 1% cream	Drug: pimecrolimus active cream Pimecrolimus 1% cream apply to affected study area twice daily for 21 days
2: Placebo Comparator Placebo cream over affected study area	Other: placebo base cream apply to affected study area twice daily for 21 days

Eligibility

Ages Eligible for Study:	2 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Children's Hospital of Michigan ( Paul J Munzenberger Pharm D Associate Professor )
Study ID Numbers:	pimecrolimus1
Study First Received:	December 17, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00810862
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Michigan:

African American children

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Pimecrolimus
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 14, 2009