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

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ClinicalTrials.gov Identifier: NCT00106496
Recruitment Status : Completed
First Posted : March 28, 2005
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Protopic Drug: Corticosteroid Drug: placebo Phase 4

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 410 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1A Drug: Protopic
topical
Other Names:
  • tacrolimus ointment
  • FK506 ointment

Active Comparator: 1B Drug: Corticosteroid
topical

Experimental: 2
Open label
Drug: Protopic
topical
Other Names:
  • tacrolimus ointment
  • FK506 ointment

Experimental: 3A Drug: Protopic
topical
Other Names:
  • tacrolimus ointment
  • FK506 ointment

Placebo Comparator: 3B Drug: placebo
topical

Experimental: 4
Open label
Drug: Protopic
topical
Other Names:
  • tacrolimus ointment
  • FK506 ointment




Primary Outcome Measures :
  1. percentage of patients reporting cutaneous adverse events during the first 2 weeks of treatment [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients reporting cutaneous adverse events overall [ Time Frame: Day 4 through end of study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106496


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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00106496     History of Changes
Other Study ID Numbers: 20-04-002
First Posted: March 28, 2005    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

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
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action