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Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: May 30, 2007
Last updated: September 17, 2014
Last verified: September 2014
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 Intervention Phase
Dermatitis, Atopic
Drug: tacrolimus ointment
Drug: Placebo ointment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Adults"

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 226
Study Start Date: April 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: tacrolimus ointment
Topical application
Other Name: Protopic®
Placebo Comparator: 2 Drug: Placebo ointment
Topical application


Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00480610

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
Principal Investigator: Use Central Contact Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00480610     History of Changes
Other Study ID Numbers: FG-506-06-40
Study First Received: May 30, 2007
Last Updated: September 17, 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 processed this record on April 28, 2017