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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04538183
• Other study ID #: DK-01/2017
• Status: Completed
• Phase: N/A
• Start date: December 4, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: September 2020
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2018
• Est. primary completion date: March 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• WO 5000
WO 5000
• WO 5001
WO 5001

Locations

Country	Name	City	State
Germany	Universitäts-Hautklinik Kiel	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of transepidermal water loss (TEWL)	Tewameter TM300, Courage & Khazaka, Köln	Change from day 1 (before application) to day 30
Primary	Change of skin hydration	Corneometer CM 825, Courage & Khazaka, Köln	Change from day 1 (before application) to day 30
Primary	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)
Primary	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)
Primary	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
Primary	Corneocyte size	After staining with Nile Red by immunofluorescence microscopy and digital imaging	Day 31
Primary	Amount of the cytokine IL-1a	Determined by enzyme-linked immunosorbent assay (ELISA)	Day 31
Primary	Amount of antimicrobial peptide hBD-2	Determined by enzyme-linked immunosorbent assay (ELISA)	Day 31