Clinical trial NCT04538183: Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
Official title: Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
First posted: 2020-09-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of transepidermal water loss (TEWL)
timeFrame: Change from day 1 (before application) to day 30
measure: Change of skin hydration
timeFrame: Change from day 1 (before application) to day 30
measure: Change of erythema
timeFrame: 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)
measure: Change of pH
timeFrame: 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)
measure: Tape-stripping
timeFrame: Day 31
measure: Corneocyte size
timeFrame: Day 31
measure: Amount of the cytokine IL-1α
timeFrame: Day 31
measure: Amount of antimicrobial peptide hBD-2
timeFrame: Day 31
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Universitäts-Hautklinik Kiel
state: Schleswig-Holstein
Study officials:
affiliation: Dr. August Wolff GmbH & Co. KG Arzneimittel
name: Sören Merker, Dr.
role: STUDY_CHAIR
References: