Healthy Women
Conditions
Keywords
Skin, pollution, Radiance
Brief summary
A randomized, double-blind, placebo-controlled study evaluating the effects of an oral antioxidant dietary supplement on skin radiance in women exposed to urban air pollution. Secondary assessments include skin tone homogeneity, pigmentation, inflammation, skin barrier function, glycation markers.
Interventions
DIETARY_SUPPLEMENTAntioxidant Supplement
Oral antioxidant dietary supplement administered as one capsule once daily for 90 days.
DIETARY_SUPPLEMENTPlacebo
Placebo dietary supplement administered as one capsule once daily for 90 days.
Sponsors
Robertet SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy female subjects aged 35 to 65 years. * Fitzpatrick skin phototype II to IV. * Any skin type. * Dull and uneven skin complexion. * Living in an urban environment and exposed to pollution. * No change in hormonal treatment within the past 3 months. * Able to understand the study procedures and provide informed consent. * Willing and able to comply with study requirements. * Written informed consent obtained. * Covered by health insurance. * Willing to avoid unprotected sun exposure and use SPF 50 sunscreen throughout the study.
Exclusion criteria
* Pregnant or breastfeeding women, or women planning to become pregnant during the study. * Current use of dietary supplements or vitamin supplements. * Participation in another clinical trial involving a cosmetic product, drug, or medical device. * Use of oral or injectable corticosteroids within the past 3 months. * Current treatment with immunosuppressive agents, chemotherapy, or radiotherapy. * History of autoimmune disease or connective tissue disorder. * Presence of an active dermatological condition that could affect study assessments. * Following a vegetarian, vegan, or weight-loss diet. * Not covered by health insurance. * Participation in another clinical study during the exclusion period. * Individuals considered vulnerable according to applicable regulations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Radiance | Day 0 and Day 90 | Glossymeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Radiance | Day 0 and Day 30 | Glossymeter |
| Skin homogeneity | Day 0, Day 30, Day 90 | VISIA CR5 |
| TransEpidermal Water Loss | Day 0, Day 30, Day 90 | Tewameter |
| Skin glycation | Day 0, Day 30, Day 90 | AGEscanner |
| skin IL8 | Day 0, Day 30, Day 90 | IL8 assay |
Countries
France
Outcome results
None listed