UMIN-ICDS Clinical Trial

Public title

A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product

Acronym

A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product

Scientific Title

A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product

Scientific Title:Acronym

A Clinical Study to Evaluate the Efficacy, Safety and Consumer Perception of a Moisturizing Product

Region

Asia(except Japan)

Condition

sensitive skin

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy for long-lasting hydration, TEWL, itch relief, reduction of redness of a test material.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of itch(VAS method), stratum corneum water content, TEWL, redness(dermatological assessment) before the application of the test material and immediately after application of the test product - after 4 weeks of continuous use.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Apply the test material to the lower leg once a day for 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

18

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Female

Key inclusion criteria

･18-65 years old females those who have extremely dry skin and pruritus, or previous experience barrier damage, eczema or atopic dermatitis
･Those who have a VAS score between 2.5 cm and 7.4 cm after using the wash-out product for 7 days.
･Those who have a redness score of 1 or more and less than 3 in visual assessment by dermatologist.
･Those who fully understand the objective and contents of the study and voluntarily decide to participate.
･Those who understand the possible adverse reactions and sign the informed consent form.
･Those who do not have acute or chronic diseases including skin diseases which can affect the study (severe infections or eczematous skin diseases including atopic dermatitis).
･Those who are available for observations throughout the entire study.
･Those who are able to visit the laboratory according to set schedules and follow the study instructions.

Key exclusion criteria

･Those who have experienced allergic reactions to cosmetics or have sensitive and hyper-sensitive skin.
･Those who are pregnant, breast feeding or planning pregnancy.
･Those who have prominent nutrition disorder.
･Those who are drug addict or alcoholic.
･Those who have moles, acne, tattoo, scars, red spots, telangiectasis, burns, etc. in the test site.
･Those who have participated in the same clinical evaluation within 6 months.
･Those who have been using steroid or retinoid for treatment of skin disease more than 1 month or are taking medicines which can affect the skin (e.g.,anti-histamines, immunosuppressants).
･Those who have used cosmetics and pharmaceuticals with similar efficacy within 3 months before starting the study.
･Those who have undergone any dermatologic procedures within 6 months.
･Those who are participating in the same clinical study/studies conducted by Ellead or other clinical institution on the same body site/sites.
･Those who have been judged by the research director to be unsuitable for enrollment in this clinical trial.

Target sample size

30

Name of lead principal investigator

1st name	AKINORI
Middle name
Last name	INOUE

Organization

LION CORPORATION

Division name

Global Development Center

Zip code

132-0035

Address

7-2-1 Hirai, Edogawa-ku, Tokyo, Japan,132-0035

TEL

08012731828

Email

ino-aki@lion.co.jp

Name of contact person

1st name	AKINORI
Middle name
Last name	INOUE

Organization

LION CORPORATION

Division name

Global Development Center

Zip code

132-0035

Address

7-2-1 Hirai, Edogawa-ku, Tokyo, Japan,132-0035

TEL

08012731828

Homepage URL

Email

ino-aki@lion.co.jp

Institute

LION CORPORATION

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ellead Co., Ltd.

Address

7&8 fl., 325, Hwangsaeul-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

Tel

+82-31-709-9070

Email

ino-aki@lion.co.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

2023

Year

12

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

30

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

Completed

Date of protocol fixation

2023

Year

11

Month

27

Day

Date of IRB

2023

Year

11

Month

27

Day

Anticipated trial start date

2023

Year

12

Month

06

Day

Last follow-up date

2024

Year

02

Month

09

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

12

Month

25

Day

Last modified on

2024

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060697