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| ID | Type | Description | Link |
|---|---|---|---|
| 22.0052-23 | Other Identifier | proderm GmbH |
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| Name | Class |
|---|---|
| proDERM GmbH | INDUSTRY |
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The aim of this study is to investigate the effect of cosmetic products with two different concentrations of the active on skin aging and in acting on the mitochondrial health of skin in comparison to a placebo product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
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| Group 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical Placebo Cream | Other | cosmetic cream to be applied topically on face and forearms twice/daily using split/face design |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in skin mitochondrial health and biological age (assessed on skin biopsies) after 8 weeks | 8 weeks | |
| Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 8-weeks | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in skin barrier function (assessed on transepidermal waterloss by Tewameter [g/(m²h)]) after 2-weeks | 2-weeks | |
| Change from baseline in skin hydration (assessed on skin capacitance by Corneometer [a.u.]) after 2 and 8 weeks | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. med. Klaus-Peter Wilhelm, Dermatologist, MD | proDERM GmbH | Study Chair |
| Dr. rer. nat. Sabrina Laing, MD | proDERM GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proderm GmbH | Schenefeld | Germany |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Split face/arm design
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| Topical Cream with 0.5% Active | Other | cosmetic cream to be applied topically on face and forearms twice/daily using split/face design |
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| Topical Cream with 1% Active | Other | cosmetic cream to be applied topically on face and forearms twice/daily using split/face design |
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| Change from baseline in pigmentation (assessed on skin color by Spectrophotometer) after 2 and 8 weeks | 8 weeks |
| Change from baseline in skin firmness by Cutometer [mm] after 2 and 8 weeks | 8 weeks |
| Change from baseline in skin elasticity by Cutometer after 2 and 8 weeks | 8 weeks |
| Change from baseline in skin layer thickness and undulation index of DEJ (assessed on Line field confocal Optical Coherence Tomography Image analysis) after 8 weeks for both groups or after 2 and 8 weeks | 8 weeks |
| Change from baseline for wrinkles and fine lines (assessed on Colorface Image analysis) after 2 and 8 weeks | 8 weeks |
| Subjective Evaluation of product traits assessed via questionnaire after 2 and 8 weeks | 2 and 8 weeks |