Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
- Conditions
- Healthy
- Interventions
- Other: WO 5000Other: WO 5001
- Registration Number
- NCT04538183
- Lead Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Male and female volunteers (75 % women and 25 % men)
- Aged 18 - 75 years
- Healthy skin
- Informed consent was given
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WO 5000 WO 5000 Body lotion pH 4 for topical application WO 5001 WO 5001 Body lotion pH 5.8 for topical application
- Primary Outcome Measures
Name Time Method Change of transepidermal water loss (TEWL) Change from day 1 (before application) to day 30 Tewameter TM300, Courage \& Khazaka, Köln
Change of erythema 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) 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
Tape-stripping Day 31 Number of the tape-strips until a threefold increase in TEWL compared to unstripped baseline value is reached. (D-Squame® (DSQ), CuDerm Corporation, Dallas)
Corneocyte size Day 31 After staining with Nile Red by immunofluorescence microscopy and digital imaging
Amount of the cytokine IL-1α Day 31 Determined by enzyme-linked immunosorbent assay (ELISA)
Change of skin hydration Change from day 1 (before application) to day 30 Corneometer CM 825, Courage \& Khazaka, Köln
Change of pH 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) pH-Meter 910, Courage \& Khazaka, Köln
Amount of antimicrobial peptide hBD-2 Day 31 Determined by enzyme-linked immunosorbent assay (ELISA)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitäts-Hautklinik Kiel
🇩🇪Kiel, Schleswig-Holstein, Germany