Treatment and Control of Atopic Dermatitis With 0.03% 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: NCT00480896
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
A long-term 0.03% 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, and reduce flares.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 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 - Children"
Study Start Date : June 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: tacrolimus ointment
Topical application
Other Names:
  • Protopic®
  • FK506 ointment
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

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Ages Eligible for Study:   2 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patient of any ethnic group
  • Patient was at least 2-15 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): NCT00480896

Bruxelles, Belgium
Czech Republic
Brno, Czech Republic
3 Sites
Praha, Czech Republic
Helsinki, Finland
Nantes, France
Paris, France
Dusseldorf, Germany
Frankfurt, Germany
Kiel, Germany
Mahlow, Germany
Budapest, Hungary
Bergamo, Italy
Parma, Italy
Roma, Italy
Amsterdam, Netherlands
Groningen, Netherlands
Nijmegen, Netherlands
Utrecht, Netherlands
Porto, Portugal
Barcelona, Spain
United Kingdom
Birmingham, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Astellas Pharma Inc
Principal Investigator: Use Central Contact Universitätsklinikum Frankfurt Zentrum für Dermatologie

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00480896     History of Changes
Other Study ID Numbers: FG-506-06-41
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:
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