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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
Intervention Model: Single Group Assignment
Masking: Single (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 ]

Secondary Outcome Measures:
  • modified IGA score [ Time Frame: at baseline, one week and three weeks following initiation of therapy ]
  • hypopigmentation scale score [ Time Frame: baseline, one and three weeks following initiation of treatment ]

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   (Child)
Sexes Eligible for Study:   All
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

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

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lactitol
Pimecrolimus
Tacrolimus
Cathartics
Gastrointestinal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 21, 2017