Healthy
Conditions
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.
Interventions
OTHERWO 5000
WO 5000
OTHERWO 5001
WO 5001
Sponsors
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of transepidermal water loss (TEWL) | Change from day 1 (before application) to day 30 | Tewameter TM300, Courage & Khazaka, Köln |
| Change of skin hydration | Change from day 1 (before application) to day 30 | Corneometer CM 825, 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 |
| 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 |
| 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) |
| Amount of antimicrobial peptide hBD-2 | Day 31 | Determined by enzyme-linked immunosorbent assay (ELISA) |
Countries
Germany
Outcome results
None listed