Back to resultsPreventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
Primary Purpose
Moderate/Severe Atopic Dermatitis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Moderate/Severe Atopic Dermatitis focused on measuring tacrolimus, Protopic, pediatric, atopic dermatitis, China
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as AD according to Williams diagnostic criteria.
- Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
- At least approximately 10 % of body area
- Patient is able to reach the centre within 3 days in case of a disease exacerbation.
- Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
continued tacrolimus treatment
no additional treatment
Arm Description
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.
Outcomes
Primary Outcome Measures
Time to first DE (disease exacerbation)
Secondary Outcome Measures
Number of DEs during the DCP
Eczema Area and Severity Index (EASI)
Investigator's Global Assessment (IGA)
Duration of DE during DCP
The overall efficacy during OLP
Quantity of tacrolimus ointment used
Incidence of adverse events
Full Information
NCT ID
NCT01745159
First Posted
December 6, 2012
Last Updated
August 4, 2014
Sponsor
Astellas Pharma China, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01745159
Brief Title
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
Official Title
Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma China, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
Detailed Description
This study includes three periods. First a screening period of up to one week. Second an open-label treatment period of up to six weeks where all participants apply tacrolimus ointment. Third an open-label disease control period of up to six months where half of the participants apply tacrolimus ointment and the other half of the participants do not apply treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate/Severe Atopic Dermatitis
Keywords
tacrolimus, Protopic, pediatric, atopic dermatitis, China
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continued tacrolimus treatment
Arm Type
Experimental
Arm Description
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.
Arm Title
no additional treatment
Arm Type
No Intervention
Arm Description
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Protopic
Primary Outcome Measure Information:
Title
Time to first DE (disease exacerbation)
Time Frame
6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)
Secondary Outcome Measure Information:
Title
Number of DEs during the DCP
Time Frame
6 months of DCP (Disease Control Period)
Title
Eczema Area and Severity Index (EASI)
Time Frame
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Title
Investigator's Global Assessment (IGA)
Time Frame
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Title
Duration of DE during DCP
Time Frame
6 months of DCP (Disease Control Period)
Title
The overall efficacy during OLP
Time Frame
After 2 to 6 weeks of OLP (Open Label Period)
Title
Quantity of tacrolimus ointment used
Time Frame
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Title
Incidence of adverse events
Time Frame
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
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:
Diagnosed as AD according to Williams diagnostic criteria.
Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
At least approximately 10 % of body area
Patient is able to reach the centre within 3 days in case of a disease exacerbation.
Patient's legal representative(s) has/have given written informed consent. If the patient is capable of understanding the purposes and risks of the trial, written informed consent has been obtained from the patient as well
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Director
Facility Information:
City
Beijing
Country
China
City
Chongqing
Country
China
City
Guangzhou
Country
China
City
Shanghai
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.jp/user/ctrSearch_e.jsp
Description
Link to Results on JAPIC - enter 140526 in the JapicCTI-RNo. field
Learn more about this trial
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
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