Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00480896
First received: May 30, 2007
Last updated: July 9, 2008
Last verified: July 2008
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Purpose
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:
|
| Placebo Comparator: 2 |
Drug: Placebo ointment
Topical application
|
Eligibility| Ages Eligible for Study: | 2 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480896
Locations
| Belgium | |
| Bruxelles, Belgium | |
| Czech Republic | |
| Brno, Czech Republic | |
| 3 Sites | |
| Praha, Czech Republic | |
| Finland | |
| Helsinki, Finland | |
| France | |
| Nantes, France | |
| Paris, France | |
| Germany | |
| Dusseldorf, Germany | |
| Frankfurt, Germany | |
| Kiel, Germany | |
| Mahlow, Germany | |
| Hungary | |
| Budapest, Hungary | |
| Italy | |
| Bergamo, Italy | |
| Parma, Italy | |
| Roma, Italy | |
| Netherlands | |
| Amsterdam, Netherlands | |
| Groningen, Netherlands | |
| Nijmegen, Netherlands | |
| Utrecht, Netherlands | |
| Portugal | |
| Porto, Portugal | |
| Spain | |
| Barcelona, Spain | |
| United Kingdom | |
| Birmingham, United Kingdom | |
| London, United Kingdom | |
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
| Principal Investigator: | Use Central Contact | Universitätsklinikum Frankfurt Zentrum für Dermatologie |
More Information
No publications provided by Astellas Pharma Inc
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Disclosure Office Europe, Astellas Pharma Europe BV |
| ClinicalTrials.gov Identifier: | NCT00480896 History of Changes |
| Other Study ID Numbers: | FG-506-06-41 |
| Study First Received: | May 30, 2007 |
| Last Updated: | July 9, 2008 |
| 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 Tacrolimus Child treatment outcomes |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate |
Hypersensitivity Immune System Diseases Tacrolimus Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013