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| Name | Class |
|---|---|
| proDERM Institut für Angewandte Dermatologische Forschung GmbH | UNKNOWN |
| Microscopy Services Dähnhardt GmbH | UNKNOWN |
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The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Negative control (untreated) for product C | No Intervention | On the forearms four test areas were located, which were labeled from A-D. Test area A contralateral to product C | |
| B - Negative control (untreated) for product D | No Intervention | On the forearms four test areas were located, which were labeled from A-D. Test area B contralateral to product D | |
| C - Cosmetic Product WO 3741 with pH 4 | Experimental | On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D. |
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| D - Cosmetic Product WO 4081-1 with pH 5.8 | Experimental | On the forearms four test areas were located, which were labeled from A-D. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| C - pH 4 Cosmetic Product WO 3741 | Other | Application of the product on the pre-defined skin area on the forearms twice daily for four weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin pH | Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter | baseline, Day 29, Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal Water Loss | Change from baseline at Day 29 and Day 30 of Transepidermal Water Loss (g/m2/h) assessed by Tewameter | baseline, Day 29, Day 30 |
| Skin Hydration | Change from baseline at Day 29 and Day 30 of Skin Hydration Arbitrary Units assessed by Corneometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Klaus-Peter Wilhelm, MD | proDERM Institute for Applied Dermatological Research, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proDERM Institute for Applied Dermatological Research | Schenefeld | Germany |
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| D - pH 5.8 Cosmetic Product WO 4081-1 | Other | Application of the product on the pre-defined skin area on the forearms twice daily for four weeks |
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| baseline, Day 29, Day 30 |
| Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS) | Change from baseline at Day 29 and Day 30 of stratum corneum assessed by transmission electron microscopy | baseline, Day 29, Day 30 |
| Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide)) | Change from baseline at Day 29 and Day 30 of corneocyte layer area assessed from the TEM data | baseline, Day 29, Day 30 |