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

This study has been completed.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
First received: March 25, 2005
Last updated: February 26, 2009
Last verified: March 2008

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

Condition Intervention Phase
Dermatitis, Atopic
Drug: Protopic
Drug: Corticosteroid
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reporting cutaneous adverse events overall [ Time Frame: Day 4 through end of study ] [ Designated as safety issue: No ]

Enrollment: 410
Study Start Date: October 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1A Drug: Protopic
Other Names:
  • tacrolimus ointment
  • FK506 ointment
Active Comparator: 1B Drug: Corticosteroid
Experimental: 2
Open label
Drug: Protopic
Other Names:
  • tacrolimus ointment
  • FK506 ointment
Experimental: 3A Drug: Protopic
Other Names:
  • tacrolimus ointment
  • FK506 ointment
Placebo Comparator: 3B Drug: placebo
Experimental: 4
Open label
Drug: Protopic
Other Names:
  • tacrolimus ointment
  • FK506 ointment

Detailed Description:

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


Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00106496

  Show 24 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

No publications provided

Responsible Party: Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00106496     History of Changes
Other Study ID Numbers: 20-04-002
Study First Received: March 25, 2005
Last Updated: February 26, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Astellas Pharma Inc:
Treatment Effectiveness
Treatment Efficacy
Immunomodulator, Topical
Tacrolimus, Topical
Dermatitis, Atopic
Eczema, Atopic
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014