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MADEC Study

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190201
Enrollment
86
Registered
2020-02-05
Start date
2020-02-17
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis Dermatitis, Atopic

Interventions

Guardian of the study subjects swabs white vaseline as basal treatment twice in a day (at cloth change in the morning and after bathing) onto the body of the study subjects as widely as possible, acco

Sponsors

Katsunuma Toshio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Change in EASI score from baseline (before starting to swab the study products) to the end of the swabbing Change in QP-CAD score from baseline (before starting to swab the study products) to the end of the swabbing

Secondary

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

Contacts

Public ContactNagatoshi Sagara

The Jikei University Daisan Hospital

n.sagara@jikei.ac.jp+81-3-3480-1151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026