UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the protective effect of crocetin on skin against UV exposure
Acronym	Evaluation of the protective effect of crocetin on skin against UV exposure
Scientific Title	A randomized, placebo-controlled, double-blind, parallel-group study of the skin-protective effects of crocetin against UV exposure
Scientific Title:Acronym	A randomized, placebo-controlled, double-blind, parallel-group study of the skin-protective effects of crocetin against UV exposure
Region	Japan

Condition
Condition	None (Healthy adults)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	Minimal erythema dose
Key secondary outcomes	Skin condition [transepidermal water loss, stratum corneum water content, skin color(L*, a*, b*), roughness (Ra) analysis by ntera3D, photography of irradiated area] Quantification of IL-1alpha and IL-1RA using tape strips

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake period: 5 weeks Test food: Soft capsule containing crocetin (7.5 mg) Once a day (1 capsule/day)
Interventions/Control_2	Intake period: 5 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

Eligibility
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 ingestion of the test product (Day 1). 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

Research contact person
Name of lead principal investigator	1st name Sumio Middle name Last name KONDO
Organization	Medical Corpoation Kenshokai Fukushima Healthcare Center
Division name	Chief of a center
Zip code	553-0004
Address	2-12-16, Tamagawa, Fukushima-ku, Osaka, Japan
TEL	06-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
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

Sponsor
Institute	RIKEN VITAMIN CO., LTD.
Institute
Department

Funding Source
Organization	RIKEN VITAMIN CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	DCR株式会社　評価センター（大阪府）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	54
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

Progress
Recruitment status	Completed
Date of protocol fixation	2022 Year 01 Month 21 Day
Date of IRB	2022 Year 01 Month 21 Day
Anticipated trial start date	2022 Year 02 Month 09 Day
Last follow-up date	2022 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete	2022 Year 07 Month 12 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 01 Day
Last modified on	2022 Year 08 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053309