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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)

Not Applicable
Conditions
Healthy volunteers
Registration Number
JPRN-UMIN000024014
Lead Sponsor
Ezaki Glico Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Skin color (L*, a*) Stratum corneum hydration Transepidermal water loss
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