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Completed

NCT Number: NCT00106496

A Multi-Center Study of Short and Long-term Use of Protopic Ointment in Patients With Atopic Dermatitis

The purpose of the study is to determine the impact of topical corticosteroids on the safety and effectiveness of Protopic Ointment in the short-term treatment of moderate to severe Atopic Dermatitis and to compare the safety and effectiveness of Protopic Ointment to placebo in the long-term management of 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

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Investigational Site, Birmingham, Alabama, United States

Loading trial locations.

About this study

Study includes an interim short-term, open label period. Patients could also receive a second course of open label treatment dependent on disease exacerbation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient must have Atopic Dermatitis
  • Patient must be at least 2 years of age

Exclusion criteria

  • Patient is pregnant or breast feeding an infant

Treatment and study plan

Protopic

Drug

topical

Other names: tacrolimus ointment, FK506 ointment

Corticosteroid

Drug

topical

Placebo

Drug

topical

Primary outcomes

  1. percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment

    Time frame: 2 weeks

Secondary outcomes

  1. Percentage of patients reporting cutaneous adverse events overall

    Time frame: Day 4 through end of study

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Multi-Center Study to Assess the Impact of Topical Corticosteroids on the Safety and Efficacy of Protopic Ointment in the Short-Term Treatment of Atopic Dermatitis and to Assess Protopic in the Long-term Management of Atopic Dermatitis

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Mar 28, 2005
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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