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Safety evaluation of children's skin care products for children with dry skin or mild atopic dermatitis

Safety evaluation of children's skin care products for children with dry skin or mild atopic dermatitis - Safety evaluation of children's skin care products

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042086
Enrollment
30
Registered
2020-10-26
Start date
2020-10-29
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

Dry skin, mild atopic dermatitis

Interventions

Test item:Moisturizing products, Cleaning products. Dose:Moisturizing products, Twice a day. Cleaning products, Once a day. Usage:Moisturizing products, Apply in the morning and evening (after bathi

Sponsors

National Center for Child health and Development
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Patients with mild to moderate dryness diagnosed by a dermatologist, or those diagnosed with mild atopic dermatitis (Those who have been diagnosed with atopic dermatitis according to the U.K. Working Party diagnostic criteria and have an EASI score of 7.0 or less.) 2)Patients aged 4 to 10 at the time of obtaining consent 3)Patients who have received sufficient explanation before participating in this test, and who have obtained the free will of the consent of the substitute after obtaining sufficient understanding.

Exclusion criteria

Exclusion criteria: 1)Persons diagnosed with moderate or higher atopic dermatitis 2)Those who may have allergic symptoms due to the tested cosmetic ingredients 3)Those who are Caucasian or Black 4)Those who participate in other clinical trials 5)In addition, if the principal investigator or co-investigators determine that it is inappropriate

Design outcomes

Primary

MeasureTime frame
Presence or absence of adverse events by severity for which a causal relationship to the test cosmetics cannot be denied after use of the test cosmetics

Secondary

MeasureTime frame
1) Existence of all adverse events by severity 2) Skin examination findings before, 2 and 4 weeks after the use of the test cosmetic, and at the appearance of a rash 3) Before use of test cosmetics, after 2 weeks and after 4 weeks stratum corneum water content, transepidermal water loss, skin pH 4) Skin components by Raman spectroscopy before, 2 and 4 weeks after use of test cosmetics: Moisture content, natural moisturizing factor, cholesterol, lactic acid, uric acid, ceramide

Countries

Japan

Contacts

Public ContactRisa Fukuda

National Center for Child Health and Development Division of Dermatology

skin_research@ncchd.go.jp03-3416-0181

Outcome results

None listed

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