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| Name | Class |
|---|---|
| SGS proderm GmbH | UNKNOWN |
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The objective of the study is to investigate the effect of one cosmetic product (exfoliator) containing Mitopure on the skin cell regeneration as well as on the skin hydration and skin barrier function in comparison to an untreated control area on the volar forearms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Untreated, stained forearm | Experimental | On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will not be applied for two weeks to the volar forearm test area. |
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| Treated, stained forearm | Experimental | On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours). The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area. |
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| Untreated, unstained forearm | Experimental | On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will not be applied for two weeks to the volar forearm test area. |
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| Treated, unstained forearm | Experimental | On day 1, the volar forearm test area will not undergo DHA staining. The cosmetic product will then be applied twice daily for two weeks to the volar forearm test area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHA stain | Other | On day 1, the volar forearm test area will undergo DHA staining (250μl of 10% DHA solution applied under occlusion with Finn Chambers for 8 hours) |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin cell regeneration quantified by change in skin color measured by Chromameter (unit of measure: Individual Typological Angle; ITA°) | Skin cell regeneration is quantified by the change in skin colour. Skin colour is measured with the Chromameter instrument (skin colour unit of measure: Individual Typological Angle [ITA°]). Therefore, skin cell regeneration is measured by the change in ITA°, such that a larger positive change in ITA° represents improved skin cell regeneration. Skin cell regeneration will be calculated 4, 8, 11, and 14 days after baseline. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Skin hydration | Change from baseline in skin hydration (assessed on skin capacitance by Corneometer) after 14 days. | 14 days |
| Skin barrier function | Change from baseline in skin barrier function (assessed on Transepidermal water loss (TEWL) by Tewameter [g/(m²h)]) after 14 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Katrin Unbereit | SGS proderm GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Schenefeld | Germany |
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On each volar forearm two test areas (each sized 3 cm x 3 cm) will be defined. Test area 1 will denote the lower right, 2 the upper right forearm. Test areas 3 and 4 on left forearm will be allocated accordingly. Each forearm test area will undergo one of four treatments (stained or unstained with DHA; and treated or untreated with cosmetic product) so all four treatments are experienced by every participant. Overall, the four treatment conditions (one treatment per test area) will be:
A) Untreated with cosmetic product, stained with DHA (negative control) B) Treated with cosmetic product, stained with DHA C) Untreated with cosmetic product, unstained (negative control) D) Treated with cosmetic product, unstained
Treatments will be randomly and balanced assigned to the four volar forearm test areas.
E) All participants will also apply two cosmetic products to the facial area.
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| Facial treatment |
| Experimental |
For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily. |
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| No DHA stain | Other | On day 1, the volar forearm test area will not undergo DHA staining. |
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| Cosmetic product application - forearm | Other | The cosmetic product will be applied twice daily for two weeks to the volar forearm test area. |
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| No cosmetic product application - forearm | Other | The cosmetic product will not be applied for two weeks to the volar forearm test area. |
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| Cosmetic products application - face | Other | For two weeks on the face (excluding eye area), a cleansing cosmetic product containing Mitopure will be applied twice daily, and the cosmetic test product (that is used on forearms) will be applied once daily. |
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| 14 days |
| Product traits | Subjective evaluation of product traits assessed via questionnaire after 14 days. Product traits will be assessed by the subjects with a list of closed questions with the following predefined identical options to tick:-2 = Fully disagree; -1 = Rather disagree; 1 = Rather agree; 2 = Fully agree | 14 days |