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Verification of the anti UV-induced inflammation effect of a plant extract ingredient. (Randomized, double-blind, placebo-controlled, parallel-group study)

Verification of the anti UV-induced inflammation effect of a plant extract ingredient. (Randomized, double-blind, placebo-controlled, parallel-group study) - Verification of the anti UV-induced inflammation effect of a plant extract.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024014
Enrollment
40
Registered
2016-09-13
Start date
2016-09-27
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 volunteers

Interventions

once a day for five weeks Placebo capsule once a day for five weeks

Sponsors

Ezaki Glico Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women aged >= 30 to <50 years 2) Those fall under the category of Fizpatrick skintype II

Exclusion criteria

Exclusion criteria: 1) Those with a diagnosis of photosensitive disorder. 2) Those who take drugs which affect skin photosensitivity. 3) Those with diagnosis of diseases on the measurement region by a medical advice. 4) Those whose MED was not detected in the measurements. 5) Those who have treated for beauty on the measurement region. 6) Those who routinely take foods, supplements and cosmetics that contain the same active ingredient. 7) Those who have treated for special skincare on the mesurement region or who have a plan to have the treatment within past 4 weeks. 8) Those who changed healthy foods or external preparation including basic skin-care products that use for measurement region, or who have begun usage of them within past 4 weeks. 9) Those who was exposed to exceeded UV-light than in daily life by activities including long hours of outwork, sports, sea bathing and leisure activities, or who have a plan it during the study period. 10) Those who engage in the night work and work in shifts day and night. 11) Those who are receiving the treatments to treat or prevent disease at medical institution at the time of receiving informed consent, or who have need of those therapy. 12) Those who have serious disorders of carbohydrate metabolism, lipid metabolism, liver function, kidney function, heart, cardiovascular, respiratory organs, endocrine system and nervous system, or with a history of psychiatric disorder. 13) Those with a history of alcoholic and drug dependency. 14) Those with allergies to cosmetics or foods. 15) Pregnant women, those who may be pregnant, lactating women at the time of receiving informed consent, or women who hope to become pregnant during the study period. 16) Those who have participated in other human studies similar to the study within past 2 months. 17) Those who have participated in other human studies within the past 4 weeks, or who plan to participate. 18) Those who were considered inappropriate for the study by an investigator.

Design outcomes

Primary

MeasureTime frame
Minimal Erythema Dose Minimal Tanning Dose Skin color (L*, a*) on the UV-irradiated region. Stratum corneum hydration and Transepidermal water loss on the UV-irradiated region.

Secondary

MeasureTime frame
Skin color (L*, a*) Stratum corneum hydration Transepidermal water loss

Countries

Japan

Contacts

Public ContactTakahiro Hemmi

Matsumoto Trading Co., Ltd. Safety Study Trust Dept.

hemmi.takahiro@matsumoto-trd.co.jp03-3241-5162

Outcome results

None listed

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