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OpenTrials
Completed

NCT Number: NCT00666302

A Comparison Study Between Protopic (Tacrolimus) Ointment and Elidel (Pimecrolimus) Cream in Treating Subjects With Atopic Dermatitis

A study to compare efficacy of Protopic Ointment to that of Elidel Cream in treating patients with Atopic Dermatitis

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Atopic Dermatitis rated at least mild using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body surface area
  • Negative pregnancy test and agrees to practice effective birth control during the study

Exclusion criteria

  • Skin disorder other than Atopic Dermatitis in the areas to be treated
  • Extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
  • Clinically infected Atopic Dermatitis at baseline
  • Likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
  • Known hypersensitivity to macrolides or any excipient of either study medication
  • Chronic condition which is either not stable or not well controlled
  • Pregnant or breast feeding an infant

Treatment and study plan

Tacrolimus ointment

Drug

topical

Other names: Protopic, FK506 ointment

pimecrolimus cream

Drug

topical

Other names: Elidel

Primary outcomes

  1. Change in Eczema Area and Severity Index (EASI)

    Time frame: 6 Weeks

Secondary outcomes

  1. Investigator's Global Atopic Dermatitis Assessment (IGADA)

    Time frame: 6 Weeks

  2. Patient's evaluation of itch

    Time frame: 6 Weeks

  3. Body surface area affected

    Time frame: 6 Weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Randomized, Investigator Blinded Study of Protopic (Tacrolimus) Ointment Vs. Elidel (Pimecrolimus) Cream in Patients With Atopic Dermatitis

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Apr 24, 2008
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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