UMIN-ICDS Clinical Trial

Public title

Evaluation of the perceived improvement in atopic dermatitis symptoms with the application of skincare products

Acronym

Evaluation of the perceived improvement in atopic dermatitis symptoms with the application of skincare products

Scientific Title

Evaluation of the perceived improvement in atopic dermatitis symptoms with the application of skincare products:
Placebo-controlled, double-blind, randomized, parallel-group comparison study

Scientific Title:Acronym

Evaluation of the perceived improvement in atopic dermatitis symptoms with the application of skincare products:
Placebo-controlled, double-blind, randomized, parallel-group comparison study

Region

Japan

Condition

Atopic dermatitis

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Apply the skincare product continuously for 8 weeks and evaluate the perceived improvement (satisfaction) in atopic dermatitis symptoms.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Medical interview
Visual examination
Evaluation of skin findings by a physician
Questionnaire evaluation
Stratum corneum analysis
Photographs

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Apply test products for 8 weeks

Interventions/Control_2

Apply placebo products for 8 weeks

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

20

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Men and women aged 20 and over with symptoms of atopic dermatitis on the face or body
(2) Subjects with an EASI score of 1.1 or higher
(3) Subjects who have not undergone treatment for atopic dermatitis for a certain period and have not used alternative therapies
(4) Subjects who have received a thorough explanation of the purpose and content of the trial, has the capacity to consent, understands it well, voluntarily agrees to participate, and has given written consent to participate in the trial

Key exclusion criteria

(1) Subjects who used topical treatments for atopic dermatitis within 4 weeks prior to the screening test date
(2) Subjects who received systemic administration (oral or intravenous) of steroids, immunosuppressants, or JAK inhibitors within 8 weeks prior to the screening test date Subjects who have undergone gastrointestinal surgery
(3) Subjects who regularly take anti-inflammatory oral medications or anti-allergy drugs
(4) Subjects who have previously received treatment with biological agents or phototherapy
(5) Subjects with a history of mental illness, diabetes, liver disease, kidney disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disorder, or other serious illnesses
(6) Subjects who have undergone gastrointestinal surgery
(7) Subjects with an ongoing medical condition
(8) Subjects of allergies to cosmetics or food (Including those who have experienced skin reactions such as rashes from cosmetics within the past year)
(9) Subjects who have significant abnormalities on the skin of the test site, or who have severe atopic dermatitis symptoms
(10) Women who wish to become pregnant during participation in this trial, women who are pregnant (including the possibility of being pregnant), or women who are breastfeeding
(11) Subjects whose skin condition changes drastically due to menstrual irregularities or menstruation
(12) Individuals who engage in intense sports and subjects who are on a diet
(13) Subjects with extremely irregular eating habits
(14) Subjects working night shifts and rotating day-night shifts
(15) Subjects who, within 4 weeks prior to the screening test date, have been exposed to ultraviolet rays through prolonged outdoor work, exercise, swimming in the sea, leisure activities, or who plan to be exposed to UV rays during the study period beyond their normal daily activities
(16)to(24)are listed in the "Other related information" column

Target sample size

40

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal medicine

Zip code

5300044

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

06-6135-5200

Email

info@miura-cl.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Terashima

Organization

Oneness Support Co., Ltd.

Division name

Clinical Trial Division

Zip code

5300044

Address

Higashitenma building 6F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

06-4801-8917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

Organization

Pias Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Ethics Committee of Miura Clinic, Medical Corporation, Kanonkai

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka

Tel

06-6135-5200

Email

mterashima@miura-cl.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

03

Month

23

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

Preinitiation

Date of protocol fixation

2026

Year

02

Month

19

Day

Date of IRB

2026

Year

02

Month

26

Day

Anticipated trial start date

2026

Year

03

Month

24

Day

Last follow-up date

2026

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

"Key exclusion criteria"
(16) Subjects who have undergone cosmetic medical treatments or special skincare procedures (such as peels or hair removal) within four weeks prior to the screening test date, or who plan to undergo such treatments during the study period.
(17) Subjects who are taking health foods that affect the skin or atopic dermatitis (including specified health foods and foods with functional claims), as well as designated quasi-drugs
(18) Subjects who are continuously undergoing treatment with pharmaceuticals (including OTC and prescription drugs)
(19) Subjects who consume more than 40 g of pure alcohol per day on average, those who drink alcohol excessively, or those who are unable to abstain from alcohol the day before the test
(20) Subjects with a history of alcohol and drug dependence
(21) Subjects who smoke an average of 21 or more cigarettes per day
(22) Subjects who are currently participating in another clinical trial (including those who plan to participate during the trial period) or who have participated in another clinical trial within the past two months
(23) Subjects who have difficulty visiting the clinic on the scheduled date
(24) Other subjects whom the principal investigator or sub-investigator deems inappropriate for the study

Registered date

2026

Year

03

Month

13

Day

Last modified on

2026

Year

03

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069658