MADEC Study

Phase 3

• Conditions: Atopic Dermatitis; Dermatitis, Atopic; D003876

• Registration Number: JPRN-jRCTs031190201
• Lead Sponsor: Katsunuma Toshio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Patients who meet all of the following criteria are included in this study:
1) Patients aged 1 years or older, and younger than 6 years at giving their consent, and who are diagnosed as atopic dermatitis based on the Guidelines of care for management of atopic dermatitis (2018) by the Japanese Dermatological Association
2) Patients whose EASI score is 7.1 or higher at acute period, and whose EASI score is diagnosed as less than 7 at the consent after treatment for 2 weeks or longer. Provided that the EASI score is determined by expert physician of allergic diseases.
3) Patients whose regal representative gives their consent to participate in the study in a written form.

Exclusion Criteria

Patients who fall into any of the following criteria are excluded from participating in the study:
1) Patients who need oral antihistamine or antibacterial agent continuously for 8 days or longer. Patients who can withdraw them during the pre-treatment period can be included in this study.
2) Patients who need systemic steroid administration, topical tacrolimus ointment, oral cyclosporine administration, ultraviolet therapy, allergen-specific immunotherapy (sublingual, subcutaneous, or oral), or moisturizing agents other than study products. Patients who can withdraw them during the pre-treatment period can be included in this study.
3) Patients who have possibility to start food allergen removal newly during the study.
4) Patients who have chronic dermatoses other than atopic dermatitis
5) Patients who have allergy to topical steroid
6) Patients with other conditions that investigator thinks unsuitable for participating in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in EASI score from baseline (before starting to swab the study products) to the end of the swabbing<br>Change in QP-CAD score from baseline (before starting to swab the study products) to the end of the swabbing

Secondary Outcome Measures

Name	Time	Method
1) Change in POEM score from baseline (before starting to swab the study products) to the end of the swabbing<br>2) Proportion of the study subject whose EASI score becomes twice or higher at the end of the swabbing compared with that at baseline<br>3) Proportion of the study subject whose POEM score becomes twice or higher at the end of the swabbing compared with that at baseline<br>4) Total usage of strong-class topical steroid