UMIN-CTR Clinical Trial

Public title

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

Acronym

Safety evaluation of children's skin care products

Scientific Title

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

Scientific Title:Acronym

Safety evaluation of children's skin care products

Region

Japan

Condition

Dry skin, mild atopic dermatitis

Classification by specialty

Pediatrics	Dermatology	Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the safety of children's skin care products after 4 weeks of use, for children aged 4 to 10 with dry skin or mild atopic dermatitis.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

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

Key secondary outcomes

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

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 bathing) to the entire body, including the face, excluding the head.
Cleaning products,
Use your hands to spread the hidden parts such as the Body and back, neck and crotch, neck and limbs, and the back of ears so that there is no wash residue. Wash your face with foam and rinse with a soft water pressure shower.
Period:4 weeks

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

4

years-old

<=

Age-upper limit

11

years-old

>

Gender

Male and Female

Key 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.

Key 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

Target sample size

30

Name of lead principal investigator

1st name	Kazue
Middle name
Last name	Yoshida

Organization

National Center for Child Health and Development

Division name

Division of Dermatology

Zip code

157-8535

Address

2-10-1,Okura,Setagayaku,Tokyo 157-8535

TEL

03-3416-0181

Email

skin_research@ncchd.go.jp

Name of contact person

1st name	Risa
Middle name
Last name	Fukuda

Organization

National Center for Child Health and Development

Division name

Division of Dermatology

Zip code

157-8535

Address

2-10-1,Okura,Setagayaku,Tokyo 157-8535

TEL

03-3416-0181

Homepage URL

Email

skin_research@ncchd.go.jp

Institute

National Center for Child health and Development

Institute

Department

Personal name

Organization

Natural Science Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Center for Child health and Development

Address

2-10-1,Okura,Setagayaku,Tokyo 157-8535

Tel

03-3416-0181

Email

rinri@ncchd.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立研究開発法人　国立成育医療研究センター (東京都)
National Center for Child Health and Development (Tokyo)

Date of disclosure of the study information

2020

Year

10

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2020

Year

09

Month

15

Day

Date of IRB

2020

Year

10

Month

19

Day

Anticipated trial start date

2020

Year

10

Month

29

Day

Last follow-up date

2023

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

10

Month

12

Day

Last modified on

2023

Year

11

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047989