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Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children

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ClinicalTrials.gov Identifier: NCT00810862
Recruitment Status : Terminated (Lack of subject enrollment over the past two years.)
First Posted : December 18, 2008
Last Update Posted : December 18, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Primecrolimus cream 1% is effective in the treatment of atopic dermatitis in African American children.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: pimecrolimus active cream Other: placebo base cream Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
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
Study Start Date : November 2006
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. modified IGA score [ Time Frame: at baseline, one week and three weeks following initiation of therapy ]
  2. hypopigmentation scale score [ Time Frame: baseline, one and three weeks following initiation of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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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
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
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 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