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Clinical Trials/JPRN-jRCTs031190201
JPRN-jRCTs031190201
Completed
Phase 3

Efficacy of a Moisturizing Cream in the Treatment of Atopic Dermatitis in Preschool Children Study

Katsunuma Toshio0 sites86 target enrollmentFebruary 5, 2020

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Katsunuma Toshio
Enrollment
86
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 5, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Katsunuma Toshio

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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