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Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00480896
First received: May 30, 2007
Last updated: July 9, 2008
Last verified: July 2008
History of Changes

May 30, 2007
July 9, 2008
June 2004
November 2005   (final data collection date for primary outcome measure)
Number of exacerbations of atopic dermatitis requiring intervention. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Number of exacerbations of atopic dermatitis requiring intervention. [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00480896 on ClinicalTrials.gov Archive Site
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 ]
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 ]
Not Provided
Not Provided
 
Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
Clinical Study on Tacrolimus Ointment Over the Long-Term. "CONTROL Study - Children"

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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dermatitis, Atopic
  • Drug: tacrolimus ointment
    Topical application
    Other Names:
    • Protopic®
    • FK506 ointment
  • Drug: Placebo ointment
    Topical application
  • Experimental: 1
    Intervention: Drug: tacrolimus ointment
  • Placebo Comparator: 2
    Intervention: Drug: Placebo ointment
Thaçi D, Reitamo S, Gonzalez Ensenat MA, Moss C, Boccaletti V, Cainelli T, van der Valk P, Buckova H, Sebastian M, Schuttelaar ML, Ruzicka T; European Tacrolimus Ointment Study Group. Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. Br J Dermatol. 2008 Dec;159(6):1348-56. Epub 2008 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
250
November 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
2 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Italy,   Netherlands,   Portugal,   Spain,   United Kingdom
 
NCT00480896
FG-506-06-41
No
Disclosure Office Europe, Astellas Pharma Europe BV
Astellas Pharma Inc
Not Provided
Principal Investigator: Use Central Contact Universitätsklinikum Frankfurt Zentrum für Dermatologie
Astellas Pharma Inc
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP