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Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

This study has been terminated.
(Lack of subject enrollment over the past two years.)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Children's Hospital of Michigan
ClinicalTrials.gov Identifier:
NCT00810862
First received: December 17, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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 4

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

Resource links provided by NLM:

U.S. FDA Resources

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

  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

No publications provided

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

Keywords provided by Children's Hospital of Michigan:
African American children

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013