Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment - Full Text View

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00480610

Purpose

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 III

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Study on Tacrolimus Ointment Over the Long-Term. "CONTROL Study - Adults"

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:	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
1: Experimental	Drug: tacrolimus ointment Topical application
2: Placebo Comparator	Drug: Placebo ointment Topical application

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480610

Locations

Austria

Innsbruck, Austria
Belgium

Edegem, Belgium

Bruxelles, Belgium
Czech Republic

Praha, Czech Republic
Denmark

Aarjus, Denmark
Finland

Helsinki, Finland
France

Paris, France

St Etienne, France
Germany

Duesseldorf, Germany

Muenchen, Germany

Bonn, Germany

Dresden, Germany
Italy

Modena, Italy

Roma, Italy
Netherlands

Amsterdam, Netherlands

Utrecht, Netherlands
Portugal

Almada, Portugal
Spain

Madrid, Spain

Barcelona, Spain
Switzerland

Geneve, Switzerland
United Kingdom

Cardiff, United Kingdom

Southhampton, United Kingdom

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Principal Investigator:

Use Central Contact

Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität

More Information

Link to results on ClinicalStudyResults.org This link exits the ClinicalTrials.gov site

Responsible Party:	Astellas Pharma Europe BV ( Disclosure Office Europe )
Study ID Numbers:	FG-506-06-40
Study First Received:	May 30, 2007
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00480610
Health Authority:	Austria: Agency for Health and Food Safety; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Switzerland: Swissmedic; Czech Republic: State Institute for Drug Control; Germany: Federal Institute for Drugs and Medical Devices; Denmark: Danish Medicines Agency; Spain: Spanish Agency of Medicines; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Italy: The Italian Medicines Agency; Netherlands: Medicines Evaluation Board (MEB); Portugal: National Pharmacy and Medicines Institute

Keywords provided by Astellas Pharma Inc:

Dermatitis, atopic
Tacrolimus
Adult
treatment outcomes

Study placed in the following topic categories:

Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate

Skin Diseases, Eczematous
Tacrolimus
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009