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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: WO 5000; Other: WO 5001

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24105
      • Universitäts-Hautklinik Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WO 5000; Body lotion pH 4 for topical application	Other: WO 5000; WO 5000
Experimental: WO 5001; Body lotion pH 5.8 for topical application	Other: WO 5001; WO 5001
No Intervention: No product use; Untreated control area

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Investigators: Study Chair: Sören Merker, Dr., Dr. August Wolff GmbH & Co. KG Arzneimittel

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2017
• Primary Completion (Actual): March 3, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: DK-01/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No