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Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

Primary Purpose

Dermatitis, Atopic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tacrolimus ointment
Placebo ointment
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Dermatitis, atopic, Tacrolimus, Child, treatment outcomes

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 3 Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Number of exacerbations of atopic dermatitis requiring intervention.

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.

Full Information

First Posted
May 30, 2007
Last Updated
September 17, 2014
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00480896
Brief Title
Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment
Official Title
Clinical Study on Tacrolimus Ointment Over the Long-term. "CONTROL Study - Children"
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Dermatitis, atopic, Tacrolimus, Child, treatment outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tacrolimus ointment
Other Intervention Name(s)
Protopic®, FK506 ointment
Intervention Description
Topical application
Intervention Type
Drug
Intervention Name(s)
Placebo ointment
Intervention Description
Topical application
Primary Outcome Measure Information:
Title
Number of exacerbations of atopic dermatitis requiring intervention.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Universitätsklinikum Frankfurt Zentrum für Dermatologie
Official's Role
Principal Investigator
Facility Information:
City
Bruxelles
Country
Belgium
City
Brno
Country
Czech Republic
Facility Name
3 Sites
City
Praha
Country
Czech Republic
City
Helsinki
Country
Finland
City
Nantes
Country
France
City
Paris
Country
France
City
Dusseldorf
Country
Germany
City
Frankfurt
Country
Germany
City
Kiel
Country
Germany
City
Mahlow
Country
Germany
City
Budapest
Country
Hungary
City
Bergamo
Country
Italy
City
Parma
Country
Italy
City
Roma
Country
Italy
City
Amsterdam
Country
Netherlands
City
Groningen
Country
Netherlands
City
Nijmegen
Country
Netherlands
City
Utrecht
Country
Netherlands
City
Porto
Country
Portugal
City
Barcelona
Country
Spain
City
Birmingham
Country
United Kingdom
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18782319
Citation
Thaci 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.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140604 in the JapicCTI-RNo. field

Learn more about this trial

Treatment and Control of Atopic Dermatitis With 0.03% Tacrolimus Ointment

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