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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000051725
Enrollment
50
Registered
2023-07-28
Start date
2023-08-08
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None (Healthy adults)

Interventions

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) Intake period: 13 weeks Test food: Pla

Sponsors

RIKEN VITAMIN CO., LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
transepidermal water loss stratum corneum water content skin color(b*) skin viscoelasticity (evaluation period: 12 or13 weeks after the start of intake)

Countries

Japan

Contacts

Public ContactNaofumi UMIGAI

RIKEN VITAMIN CO., LTD. Healthcare Unit

nao_umigai@rike-vita.co.jp03-5362-1334

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026