atopic dermatitis
Conditions
Interventions
Proactive therapy with topical agents alone
Proactive therapy with topical agents plus an antihistamine (levocetirizine hydrochloride) at dose of 5mg once a day
Sponsors
Non-Profit Organization Health Institute Research of Skin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The first stage 1) Patients who are diagnosed as AD 2) Patients with more than moderate AD (according to severity scoring by JDA) who are needed daily treatment of steroids and tacrolimus. 3) Patients who are obtainable written informed consent. 4) Patients with more than 16 years old who are diagnosed as AD. ?Should be obtained written informed consent by the legally authorized representative If he or she is less than 20 years old. * moderate AD : according to severity scoring by Severity Score Index according to Standard guideline for management (authorized by Japanese Dermatological Association) The second stage 1) Subjects who were registered in 1st phase, and also had the inflammation symptom subside within 4 weeks during the course of standard therapy defined in the JDA guideline. 2) Subjects who had recurrence of inflammation symptom will be receive the standard therapy defined in the JDA guideline again. 3) Patients who are obtainable written informed consent about the second stage investigation. * should be obtained written informed consent by the legally authorized representative If he or she is less than 20 years-old.
Exclusion criteria
Exclusion criteria: The first stage 1) Patients who have the history of hypersensitivity to any of the study drug. 2) Women who are pregnant,delivery, ,location or person who hope the pregnancy of the partne.. 3) Unsuitability as determined by the study doctor. The second stage 1) Patients who have the history of hypersensitivity to any of the study drug. 2) Women who are pregnant,delivery, ,location or person who hope the pregnancy of the partne. 3) Unsuitability as determined by the study doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of the maintenance phase of Atopic Dermatitis(time to recurrence of inflammation) | — |
Countries
Japan
Contacts
Public ContactYasunari Hiramatsu
Non-Profit Organization Health Institute Research of Skin secretariat
Outcome results
None listed