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| Name | Class |
|---|---|
| proDERM GmbH | INDUSTRY |
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The purpose of this study is to evaluate the anti-wrinkle efficacy and effect on skin epigenetic and on mitochondrial morphology of a facial cosmetic product compared to a placebo
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Cream | Experimental |
| |
| Active Moisturizing Cream | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mitopure (Urolithin A) Cream | Other | cosmetic cream to be applied topically on face and forearms twice/daily using split/face design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anti-wrinkle efficacy | Anti-wrinkle efficacy will be assessed in the periorbital regions wrinkles using AEVA. Parameters measured: Rz and Ra, representing mainly the rough structure (Rz) or the finer skin structure (Ra). | 12 weeks |
| Skin Biological age | DNA methylation patterns analysis (epigenetics) by skin tape stripping (D-Squames) | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skin hydration | Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) | 12 weeks |
| Transepidermal Water Loss (TEWL) | Change from baseline in skin barrier function (assessed as transepidermal waterloss by Tewameter [g/(m²h)]) |
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Inclusion Criteria:
For biopsy subpanel:
-Vaccination of tetanus within the last 10 years
Exclusion Criteria:
For biopsy subpanel:
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| Name | Affiliation | Role |
|---|---|---|
| Katrin Unbereit, PhD | SGS proderm GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Schenefeld | Free and Hanseatic City of Hamburg | 22869 | Germany |
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| ID | Term |
|---|---|
| C026423 | 3,8-dihydroxy-6H-dibenzo(b,d)pyran-6-one |
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| Placebo Cream | Other | cosmetic cream to be applied topically on face and forearms twice/daily using split/face design |
|
| 12 weeks |
| Mitochondrial morphology in skin | mitochondrial morphology in skin will be assessed via transmission electron microscopy (TEM) on 3mm punch-biopsies | 12 weeks |
| Photodocumentation of skin health | ColorFace image analysis of face via facial photography | 12 weeks |
| Subjective questionnaire | Subjective evaluation of product traits assessed via questionnaire | 12 weeks |