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Completed

NCT Number: NCT04538183

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.

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäts-Hautklinik Kiel

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WO 5000

Other

WO 5000

WO 5001

Other

WO 5001

Primary outcomes

  1. Change of transepidermal water loss (TEWL)

    Time frame: Change from day 1 (before application) to day 30

    Tewameter TM300, Courage & Khazaka, Köln

  2. Change of skin hydration

    Time frame: Change from day 1 (before application) to day 30

    Corneometer CM 825, Courage & Khazaka, Köln

  3. Change of erythema

    Time frame: 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

  4. Change of pH

    Time frame: 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

  5. Tape-stripping

    Time frame: 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)

  6. Corneocyte size

    Time frame: Day 31

    After staining with Nile Red by immunofluorescence microscopy and digital imaging

  7. Amount of the cytokine IL-1α

    Time frame: Day 31

    Determined by enzyme-linked immunosorbent assay (ELISA)

  8. Amount of antimicrobial peptide hBD-2

    Time frame: Day 31

    Determined by enzyme-linked immunosorbent assay (ELISA)

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 4, 2020
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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