Clinical trial NCT00480610: Treatment and Control of Atopic Dermatitis With 0.1% Tacrolimus Ointment
Official title: Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Adults"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: Dermatitis, atopic
Tacrolimus
Adult
treatment outcomes
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 226
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility 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

Primary outcomes:
measure: Number of exacerbations of atopic dermatitis requiring intervention.
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Praha
country: Czech Republic
city: Aarjus
country: Denmark
city: Helsinki
country: Finland
city: Paris
country: France
city: St Etienne
country: France
city: Bonn
country: Germany
city: Dresden
country: Germany
city: Duesseldorf
country: Germany
city: Muenchen
country: Germany
city: Modena
country: Italy
city: Roma
country: Italy
city: Amsterdam
country: Netherlands
city: Utrecht
country: Netherlands
city: Almada
country: Portugal
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Geneve
country: Switzerland
city: Cardiff
country: United Kingdom
city: Southhampton
country: United Kingdom
Study officials:
affiliation: Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians Universität
name: Use Central Contact
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wollenberg A, Reitamo S, Girolomoni G, Lahfa M, Ruzicka T, Healy E, Giannetti A, Bieber T, Vyas J, Deleuran M; European Tacrolimus Ointment Study Group. Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. Allergy. 2008 Jul;63(7):742-50.
citation: Wollenberg A, Sidhu MK, Odeyemi I, Dorsch B, Koehne-Volland R, Schaff M, Ehlken B, Berger K. Economic evaluation of maintenance treatment with tacrolimus 0.1% ointment in adults with moderate to severe atopic dermatitis. Br J Dermatol. 2008 Dec;159(6):1322-30. doi: 10.1111/j.1365-2133.2008.08807.x. Epub 2008 Sep 6.