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.
Investigators
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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