Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Treatments: Tacrolimus

Criteria

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