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Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480610
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
Long-term tacrolimus ointment based regimen comprising of up to 6 weeks of initial twice daily treatment and subsequent twice weekly prophylactic application can effectively treat active lesions of atopic dermatitis and prevent delay & reduce flares

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: tacrolimus ointment Drug: Placebo ointment Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Adults"
Study Start Date : April 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus ointment
Topical application
Other Name: Protopic®

Placebo Comparator: 2 Drug: Placebo ointment
Topical application

Primary Outcome Measures :
  1. Number of exacerbations of atopic dermatitis requiring intervention. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Time to first exacerbation requiring intervention; exacerbation treatment days, periods and time to first exacerbation; physician and patient assessment of affected area, treatment response; quality of life; global response [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patient of any ethnic group
  • Patient was at least 16 years old and suffered from mild to severe atopic dermatitis (Rajka/Langeland score of at least 3)

Exclusion Criteria:

  • Patient had a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
  • Patient had a clinically significant skin infection on the affected (and to be treated) area

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 identifier (NCT number): NCT00480610

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Innsbruck, Austria
Bruxelles, Belgium
Edegem, Belgium
Czech Republic
Praha, Czech Republic
Aarjus, Denmark
Helsinki, Finland
Paris, France
St Etienne, France
Bonn, Germany
Dresden, Germany
Duesseldorf, Germany
Muenchen, Germany
Modena, Italy
Roma, Italy
Amsterdam, Netherlands
Utrecht, Netherlands
Almada, Portugal
Barcelona, Spain
Madrid, Spain
Geneve, Switzerland
United Kingdom
Cardiff, United Kingdom
Southhampton, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
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Principal Investigator: Use Central Contact Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität
Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00480610    
Other Study ID Numbers: FG-506-06-40
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Dermatitis, atopic
treatment outcomes
Additional relevant MeSH terms:
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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
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action