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The objective of the study was to examine whether normalizing of the pH by acidification through topical treatment helps to strengthen the skin barrier, to induce epidermal differentiation and to reduce inflammation in healthy individuals.
Previous studies have shown that an emollient adjusted to pH 4 has favorable effects to the skin of aged individuals. The objective of the study was to examine whether normalizing of the pH by acidification through topical treatment helps to strengthen the skin barrier, to induce epidermal differentiation and to reduce Inflammation. The effect of a cosmetic oil-in-water (O/W) emulsion adjusted to pH 4 in comparison to the same emulsion adjusted to pH 5.8 on the integrity of the skin barrier and the mechanical stability was examined in healthy volunteers from age 18 to 75 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WO 5000 | Experimental | Body lotion pH 4 for topical application |
|
| WO 5001 | Experimental | Body lotion pH 5.8 for topical application |
|
| No product use | No Intervention | Untreated control area |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WO 5000 | Other | WO 5000 |
| |
| WO 5001 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of transepidermal water loss (TEWL) | Tewameter TM300, Courage & Khazaka, Köln | Change from day 1 (before application) to day 30 |
| Change of skin hydration | Corneometer CM 825, Courage & Khazaka, Köln | Change from day 1 (before application) to day 30 |
| Change of erythema | Visible score adapted from Frosch and Kligman: 0 = no redness, 0.5 = very slight redness, 1 = slight patchy or diffuse redness, 2 = moderate even redness, 3 = profound redness | Change from Day 1 to day 30 + 2 hours (after tape-stripping), measured over 3 timepoints (Day 1, day 30 and day 30 +2 hours (after tape stripping) |
| Change of pH | pH-Meter 910, Courage & Khazaka, Köln | Change from Baseline to day 31, measured over 5 time points (Day 1, day 30, day 30+3 hours, day 30+6 hours and day 31) |
| Tape-stripping | Number of the tape-strips until a threefold increase in TEWL compared to unstripped baseline value is reached. (D-Squame® (DSQ), CuDerm Corporation, Dallas) | Day 31 |
| Corneocyte size | After staining with Nile Red by immunofluorescence microscopy and digital imaging | Day 31 |
| Amount of the cytokine IL-1α | Determined by enzyme-linked immunosorbent assay (ELISA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sören Merker, Dr. | Dr. August Wolff GmbH & Co. KG Arzneimittel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Hautklinik Kiel | Kiel | Schleswig-Holstein | 24105 | Germany |
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Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
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The test areas were 5 x 5 cm squares on both inner (volar) forearms. The areas were randomized and double-blinded (regarding the two test products). For randomization, the permutated orthogonal Latin square method was used on condition that both test areas are always contralateral.
| Other |
WO 5001 |
|
| Day 31 |
| Amount of antimicrobial peptide hBD-2 | Determined by enzyme-linked immunosorbent assay (ELISA) | Day 31 |