Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8

Conditions
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Healthy

Intervention / Treatment
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* Other: WO 5000
* Other: WO 5001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female volunteers (75 % women and 25 % men) Aged 18 - 75 years Healthy skin Informed consent was given Exclusion Criteria: Atopic diathesis, atopic dermatitis and other skin diseases with a disrupted skin barrier Dermatitis and other skin diseases in the test site Birthmarks, tattoos, scars and other abnormalities in the test site, which may influence the measurements Women: pregnancy and breastfeeding Known contact sensitization Severe systemic diseases Regular use of sauna and solarium Intensive UV exposure Topical use of drugs in the test site four weeks before and during the study Systemic administration of anti-inflammatory, immune-modulating and antibiotic drugs Previous participation in other studies within the last month before the study Alcohol and drug misuse Missing awareness and inability to follow the instructions of the study staff Other reasons which according to the study leader speak against the participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WO 5000<br>Body lotion pH 4 for topical application | Other: WO 5000<br>* WO 5000<br>|
| Experimental: WO 5001<br>Body lotion pH 5.8 for topical application | Other: WO 5001<br>* WO 5001<br>|
| No Intervention: No product use<br>Untreated control area | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | Day 31 | 
| Amount of antimicrobial peptide hBD-2 | Determined by enzyme-linked immunosorbent assay (ELISA) | Day 31 |