UMIN-ICDS Clinical Trial

Public title

Parallel-group comparative study on the skin moisturizing effects of PapriX^(R) oral intake

Acronym

Parallel-group comparative study on the skin moisturizing effects of PapriX^(R) oral intake

Scientific Title

Parallel-group comparative study on the skin moisturizing effects of PapriX^(R) oral intake

Scientific Title:Acronym

Parallel-group comparative study on the skin moisturizing effects of PapriX^(R) oral intake

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test product on skin in healthy Japanese.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of transepidermal water loss (TEWL) (left forearm) at 8 weeks after intervention (8w)

Key secondary outcomes

1. The measured values of TEWL (right cheek), the moisture content of skin (right cheek), the moisture content of skin (left forearm), skin viscoelasticity (R0~R9) (right cheek) and skin viscoelasticity (R0~R7) (left forearm) at 8w

2. The measured values of TEWL (left forearm), TEWL (right cheek), the moisture content of skin (right cheek), the moisture content of skin (left forearm), skin viscoelasticity (R0~R9) (right cheek) and skin viscoelasticity (R0~R7) (left forearm) at 4 weeks after intervention (4w)

3. Skin moisture, skin texture, sagging of the skin, skin elasticity, skin viscoelasticity, skin glow, skin brightness, skindex-16 total score, questions about symptoms (item 1~4), questions about emotions (item 5~11), questions about functioning (item 12~16) and each item in skindex-16 at 4w and 8w.

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

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Duration: Eight weeks
Test product: Soft capsule containing PapriX^(R) (xanthophyll derived from red bell pepper)
Administration: Consume one capsule per day with water at dinner.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

Interventions/Control_2

Duration: Eight weeks
Test product: Soft capsule not containing PapriX^(R)
Administration: Consume one capsule per day with water at dinner.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults

4. Healthy individuals

5. Individuals whose TEWL (arm) is high at screening (Scr)

Key exclusion criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking medicines (including herbal medicines) or supplements

6. Individuals who have been diagnosed with atopic dermatitis

7. Individuals who use any products except for cosmetic creams, beauty essence, all-in-one cosmetic makeup, face masks, skin lotions, milky lotions, and sunscreen for daily skincare

8. Individuals who habitually receive skincare treatment (e.g., aesthetic treatment) or use instruments for beauty treatment (e.g., facial treatment device)

9. Individuals who have undergone cosmetic surgery

10. Individuals who are allergic to medicines or foods related to the test product (particularly, green pepper or bell pepper)

11. Individuals who are pregnant, lactating, or planning to become pregnant during this study

12. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

13. Individuals who receive hormone replacement therapy

14. Individuals whose lifestyle may majorly change (such as long-term travel) during this study

15. Individuals who are judged as ineligible to participate in this study by the physician

Target sample size

38

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Izumi

Organization

Hiroo Dermatology Clinic & Mentors inc.

Division name

Director

Zip code

150-0012

Address

1&2F Hiroo Masugi Annex Bldg., 5-25-5, Hiroo, Shibuya-ku, Tokyo, Japan

TEL

03-5795-1112

Email

dr_izumi@orthomedico.jp

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

Glico Nutrition Co., Ltd.

Institute

Department

Personal name

Organization

Glico Nutrition Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

広尾皮フ科クリニック (東京都)
Hiroo Dermatology Clinic & Mentors inc. (Tokyo, Japan)

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2025

Year

11

Month

18

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

Open public recruiting

Date of protocol fixation

2025

Year

11

Month

12

Day

Date of IRB

2025

Year

11

Month

12

Day

Anticipated trial start date

2025

Year

11

Month

18

Day

Last follow-up date

2026

Year

03

Month

24

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

11

Month

18

Day

Last modified on

2025

Year

11

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068389