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OpenTrials
Completed

NCT Number: NCT00666159

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

Comparison of Protopic Ointment to Elidel Cream to assess the safety and efficacy in pediatric patients with Atopic Dermatitis

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Key information

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New Haven, Connecticut, United States

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About this study

This is a two arm, randomized, investigator blinded study to compare Protopic Ointment to Elidel Cream in treating pediatric patients with moderate to severe Atopic Dermatitis

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of Atopic Dermatitis which is rated moderate, severe or very severe using the Investigator's Global Atopic Dermatitis Assessment involving a minimum of 5% of the body's surface area
  • If female, and of childbearing potential, patient has a negative pregnancy test and agrees to practice effective birth control during the study

Exclusion criteria

  • Patient has a skin disorder other than Atopic Dermatitis in the areas to be treated
  • Patient has extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters
  • Patient has clinically infected Atopic Dermatitis at baseline
  • Patient is likely to require systemic corticosteroids, or the patient is likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug
  • Patient has a known hypersensitivity to macrolides or any excipient of either study medication
  • Patient has a chronic condition which is either not stable or not well controlled
  • Patient is 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 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 Pediatric Patients With Moderate to Severe 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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