Treatment and Control of Atopic Dermatitis With 0.03% 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
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 Intervention Phase
Dermatitis, Atopic
Drug: tacrolimus ointment
Drug: Placebo ointment
Phase 3

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: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children"

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: June 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 Names:
  • Protopic®
  • FK506 ointment
Placebo Comparator: 2 Drug: Placebo ointment
Topical application


Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT00480896     History of Changes
Other Study ID Numbers: FG-506-06-41 
Study First Received: May 30, 2007
Last Updated: September 17, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Portugal: National Pharmacy and Medicines Institute

Keywords provided by Astellas Pharma Inc:
Dermatitis, atopic
treatment outcomes

Additional relevant MeSH terms:
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 23, 2016