UMIN-ICDS Clinical Trial

Public title

Evaluation of the protective effect of paprika carotenoid extract on skin against UV exposure

Acronym

Evaluation of the protective effect of paprika carotenoid extract on skin against UV exposure

Scientific Title

Evaluation of the protective effect of paprika carotenoid extract on skin against UV exposure : A randomized, placebo-controlled, double-blind, parallel-group study

Scientific Title:Acronym

Evaluation of the protective effect of paprika carotenoid extract on skin against UV exposure : A randomized, placebo-controlled, double-blind, parallel-group study

Region

Japan

Condition

None (Healthy adults)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects of test food intake on UV-induced skin deterioration in healthy adult Japanese men and women.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Erythema intensity (delta a* : the difference of a* value between the UV irradiated fields and a non-irradiated area) and minimal erythema dose

(evaluation period : 12 weeks after the start of intake)

Key secondary outcomes

transepidermal water loss
stratum corneum water content
skin color(b*)
skin viscoelasticity

(evaluation period: 12 or13 weeks after the start of intake)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake period: 13 weeks
Test food: Soft capsule containing 20 mg of paprika carotenoid extract (Carotenoids content 1.4 mg/capsule)
Once a day (1 capsule/day)

Interventions/Control_2

Intake period: 13 weeks
Test food: Placebo soft capsule
Once a day (1 capsule/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

30

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1. healthy adult males and females between the ages of 30 and 60 years at the time of consent
2. have a Fitzpatrick skin phototype of type II or III
3. Participants whose dorsal skin can be determined to have UV erythema.
4. Participants who were judged to have MED in the second, third, or fourth of the six levels of UV radiation at the time of MED judgment before intake of the test food.
5. Participants who be able to visit the test site on all test days
6. Those who can provide written consent to participate in the study voluntarily.

Key exclusion criteria

1. smoker
2. patients with a history of atopic dermatitis or a predisposition to atopy
3. those who have factors on the skin of the evaluation site that may affect the results of the test
4. those who have been diagnosed as photosensitive
5. those who have undergone or will undergo cosmetic procedures on the evaluation site
6. those who have undergone any special skin care treatment within the past 4 weeks, or plan to do so during the examination period
7. participants who have continuously used skin care products or health foods that advocate or emphasize efficacy similar to or related to the efficacy to be studied in this study
8. those who have changed or newly started using health food products or basic cosmetics or sunscreen products within the past four weeks
9. those who have been or will be exposed to ultraviolet radiation beyond their daily activities within the past 4 weeks
10. those who may be allergic to food
11. those who have been taking medicines which are indicated for the treatment of freckles, pigmentation due to sunburn, and melasma
12. those who work night shifts or day/night shifts
13. those who are undergoing medical treatment for the treatment or prevention of disease at the time of obtaining consent, or those who are judged to be in need of treatment
14. those who are taking drugs that affect the photosensitivity of the skin
15. those who continuously use or take anti-inflammatory drugs at least once a month
16. participants who had a history of serious diseases.
17. undergoing hormone replacement therapy for menopause or postmenopausal women, or those who have not been under treatment for at least 6 months
18. those with a history of alcohol or drug dependence.
19. pregnant or lactating at the time of consent, or who wish to become pregnant during the study period
20. those who have participated in other human studies within the past 4 weeks
21. those who are judged as unsuitable to participate in the study by the principal investigator

Target sample size

50

Name of lead principal investigator

1st name	Sumio
Middle name
Last name	KONDO

Organization

Medical Corpoation Kenshokai Fukushima Healthcare Cente

Division name

Medical Corpoation Kenshokai Fukushima Healthcare Cente

Zip code

553-0004

Address

2-12-16, Tamagawa, Fukushima-ku, Osaka, Japan

TEL

06-6882-1130

Email

s.kondo@drc-web.co.jp

Name of contact person

1st name	Naofumi
Middle name
Last name	UMIGAI

Organization

RIKEN VITAMIN CO., LTD.

Division name

Healthcare Unit

Zip code

160-0004

Address

1-6-1 Yotsuya, Shinjuku-ku, Tokyo, Japan

TEL

03-5362-1334

Homepage URL

Email

nao_umigai@rike-vita.co.jp

Institute

RIKEN VITAMIN CO., LTD.

Institute

Department

Personal name

Organization

RIKEN VITAMIN CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Brain Care Clinic Ethical Review Board

Address

2-1-2 Shinjuku, Shinjuku-ku, Tokyo, Japan

Tel

06-6882-1130

Email

ethics_board@drc-web.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

DRC株式会社　評価センター（大阪府）

Date of disclosure of the study information

2023

Year

07

Month

28

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

2023

Year

07

Month

13

Day

Date of IRB

2023

Year

07

Month

13

Day

Anticipated trial start date

2023

Year

08

Month

08

Day

Last follow-up date

2023

Year

12

Month

13

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

07

Month

27

Day

Last modified on

2023

Year

09

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059028