Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

Phase 4

Completed

• Conditions: Moderate/Severe Atopic Dermatitis
• Interventions: Drug: tacrolimus

• Registration Number: NCT01745159
• Lead Sponsor: Astellas Pharma China, Inc.

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continued tacrolimus treatment	tacrolimus	children with moderate/severe atopic dermatitis treated with tacrolimus ointment and continuing to apply tacrolimus ointment during disease control period.

Primary Outcome Measures

Name	Time	Method
Time to first DE (disease exacerbation)	6 months of DCP(Disease Control Period) after 2 to 6 weeks of OLP(Open Label Period)

Secondary Outcome Measures

Name	Time	Method
Number of DEs during the DCP	6 months of DCP (Disease Control Period)
The overall efficacy during OLP	After 2 to 6 weeks of OLP (Open Label Period)
Investigator's Global Assessment (IGA)	6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Incidence of adverse events	6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Eczema Area and Severity Index (EASI)	6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)
Duration of DE during DCP	6 months of DCP (Disease Control Period)
Quantity of tacrolimus ointment used	6 months of DCP (Disease Control Period) after 2 to 6 weeks of OLP (Open Label Period)