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The study is aimed to assess the efficacy of two dietary supplements composed of berry extracts in reducing skin aging signs and improving skin complexion.
A double blind, parallel groups, placebo-controlled study is carried out on 90 healthy female subjects aged between 35 and 65 (±2) years old with phototypes from I to III, uneven skin tone, visible Crow's feet wrinkles and mild-moderate skin slackness at cheek level.
The study foresees 84 days of products intake. Evaluations of the parameters under study are performed at baseline, after 28, 56 and 84 days of products consumption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berry extract 1 | Experimental | Dietary supplement - Berry extract 1 |
|
| Berry extract 2 | Experimental | Dietary supplement - Berry extract 2 |
|
| Placebo | Placebo Comparator | Dietary supplement - Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berry extract 1 | Dietary Supplement | The study foresees the intake of 1 capsule per day during 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin profilometry | Primos 3D | Baseline |
| Skin profilometry | Primos 3D | 28 days |
| Skin profilometry | Primos 3D | 56 days |
| Skin profilometry | Primos 3D | 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Skin elasticity | Cutometer | Baseline |
| Skin elasticity | Cutometer | 28 days |
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Inclusion criteria :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ileana De Ponti | Complife Italia Srl | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complife Italia srl | Milan | 20024 | Italy |
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| Berry extract 2 | Dietary Supplement | The study foresees the intake of 1 capsule per day during 84 days |
|
| Placebo | Dietary Supplement | The study foresees the intake of 1 capsule per day during 84 days |
|
| Skin elasticity |
Cutometer |
| 56 days |
| Skin elasticity | Cutometer | 84 days |
| Skin color | CIELab color space | Baseline |
| Skin color | CIELab color space | 28 days |
| Skin color | CIELab color space | 56 days |
| Skin color | CIELab color space | 84 days |
| Crow's feet | Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland) | Baseline |
| Crow's feet | Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland) | 28 days |
| Crow's feet | Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland) | 56 days |
| Crow's feet | Clinical evaluation (Skin Aging Atlas - Caucasian and Asian Type - Bazin Roland) | 84 days |
| Skin firmness | Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin) | Baseline |
| Skin firmness | Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin) | 28 days |
| Skin firmness | Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin) | 56 days |
| Skin firmness | Clinical scoring (internal validated scale from 1 to 5, where: 1 = not firm skin and 5 = very firm skin) | 84 days |
| Skin homogeneity improvment from baseline | Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation) | 28 days |
| Skin homogeneity improvment from baseline | Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation) | 56 days |
| Skin homogeneity improvment from baseline | Clinical scoring (internal validated scale from 1 to 4, where: 1 = no variation and 4 = evident variation) | 84 days |
| Self-assessment of product efficacy | Questionnaire (20 questions with 4 possible answers : completely agree / agree / disagree / completely disagree) | 84 days |
| Skin antioxidant potential | FRAP (Ferric Reducing Antioxidant Power) assay | Baseline |
| Skin antioxidant potential | FRAP (Ferric Reducing Antioxidant Power) assay | 84 days |