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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014