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Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect (Randomized, double-blind, placebo-controlled, parallel-group study)

Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect (Randomized, double-blind, placebo-controlled, parallel-group study) - Clinical evaluation of intake of a plant extract ingredient in preventing ultraviolet(UV)-induced inflammation effect

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000025593
Enrollment
40
Registered
2017-01-12
Start date
2017-01-16
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

Healthy subjects

Interventions

test food (6 tablets once a day for nine weeks) Placebo food (6 tablets once a day for five weeks)

Sponsors

Shiseido Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: A person who is a healthy person who does not fall under the following exclusion criteria and whose age at the time of consent acquisition date is from 20 years old to under 59 years old and who give written informed consent 1) Subjects without apparent pigmentation, inflammation, and other abnormalities at the test site 2) Subjects whose skin will sunburn (form erythema) easily and does not develop a tan by UV irradiation (Fizpatrick skin type I or II) 3) Subjects who has a relatively low daily intake of goji berry, tea with whitening effect 4) Subjects who are judged as suitable for the study by the investigator

Exclusion criteria

Exclusion criteria: 1) Subjects with apparent pigmentation, inflammation, and other significant abnormalities at the test site 2) Subjects with history of photo sensitivity 3) Subjects with risk of allergy regarding to test food 4) Subjects who have excessive sunburn in 3 months 5) Subjects who have chronic skin symptoms such as atopic dermatitis at the test site 6) Subjects who is in pregnancy, or plan to get pregnant during this study period 7) Subjects who have chronic diseases such as asthma and who regularly use drugs 8) Subjects who presently take medications that are effective for liver spots, spots, freckles and pigmentation due to sunburns, such as L-cysteine-containing drugs, vitamin-C-containing drugs and tranexamic acid-containing drugs that are thought to affect the evaluation 9) Subjects who used supplements for cosmetic (especially whitening) supplements for more than 5 days a week within past 3 months (products that prompted antioxidant action such as catechin, flavonoids and high content of polyphenols) 10) Subjects who have participated in other clinical trials within the past 3 months, or who plan to participate 11) Subjects with smoking habit 12) Subjects who used external use medicine to the test site within past one week 13) Subjects who have a plan to go abroad, sea bathing, etc. during the study period 14) Subjects who has receiving menopausal disorder and postmenopausal "hormone replacement therapy" 15) Subjects who are judged as unsuitable for the study by the investigator for other reason

Design outcomes

Primary

MeasureTime frame
Skin color (L*, a*, erythema index, melanin index) on the UV-irradiated region after 1.5 MED UV irradiation at 0, 8 weeks after the intake

Secondary

MeasureTime frame
Minimal Erythema Dose Minimal Tanning Dose Skin color (L*, a*) Stratum corneum hydration Transepidermal water loss changes of anti-oxidants in serum

Countries

Japan

Contacts

Public ContactMakoto Tsunenaga

Shiseido Co., Ltd. Advanced Research Center

makoto.tsunenaga@to.shiseido.co.jp045-590-6000

Outcome results

None listed

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