Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

August 4, 2014 updated by: Astellas Pharma China, Inc.

Proactive Treatment With Tacrolimus Ointment in Children With Moderate/Severe Atopic Dermatitis: A Randomized, Multicenter, Open-label Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Chongqing, China
      • Guangzhou, China
      • Shanghai, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosed as AD according to Williams diagnostic criteria.
  2. Moderate or severe atopic dermatitis according to the criteria of Rajka and Langeland
  3. At least approximately 10 % of body area
  4. Patient is able to reach the centre within 3 days in case of a disease exacerbation.
  5. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: continued tacrolimus treatment
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.
Drug: tacrolimus
Other Names:
  • Protopic
No Intervention: no additional treatment
children with moderate/severe atopic dermatitis treated with tacrolimus ointment and with no additional treatment during disease control period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of DEs during the DCP
Time Frame: 6 months of DCP (Disease Control Period)
6 months of DCP (Disease Control Period)
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)
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Investigator's Global Assessment (IGA)
Time Frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Duration of DE during DCP
Time Frame: 6 months of DCP (Disease Control Period)
6 months of DCP (Disease Control Period)
The overall efficacy during OLP
Time Frame: After 2 to 6 weeks of OLP (Open Label Period)
After 2 to 6 weeks of OLP (Open Label Period)
Quantity of tacrolimus ointment used
Time Frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Incidence of adverse events
Time Frame: 6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma China, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

December 6, 2012

First Submitted That Met QC Criteria

December 6, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACN-PRT-AD-12-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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