Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480896
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

May 30, 2007
May 31, 2007
September 18, 2014
June 2004
November 2005   (Final data collection date for primary outcome measure)
Number of exacerbations of atopic dermatitis requiring intervention. [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT00480896 on 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 ]
Same as current
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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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. doi: 10.1111/j.1365-2133.2008.08813.x. Epub 2008 Sep 6.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
2 Years to 15 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Italy,   Netherlands,   Portugal,   Spain,   United Kingdom
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Principal Investigator: Use Central Contact Universitätsklinikum Frankfurt Zentrum für Dermatologie
Astellas Pharma Inc
September 2014

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