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

Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel (Industry)
Overall Status
Completed
CT.gov ID
NCT04538183
Collaborator
(none)
25
Enrollment
1
Location
3
Arms
6.8
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: WO 5000
  • Other: WO 5001
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparisonExploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
Masking:
Quadruple (Participant, Care Provider, 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.
Primary Purpose:
Supportive Care
Official Title:
Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
Actual Study Start Date :
Dec 4, 2017
Actual Primary Completion Date :
Mar 3, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change of transepidermal water loss (TEWL) [Change from day 1 (before application) to day 30]

    Tewameter TM300, Courage & Khazaka, Köln

  2. Change of skin hydration [Change from day 1 (before application) to day 30]

    Corneometer CM 825, Courage & Khazaka, Köln

  3. 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

  4. 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

  5. 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)

  6. Corneocyte size [Day 31]

    After staining with Nile Red by immunofluorescence microscopy and digital imaging

  7. Amount of the cytokine IL-1α [Day 31]

    Determined by enzyme-linked immunosorbent assay (ELISA)

  8. Amount of antimicrobial peptide hBD-2 [Day 31]

    Determined by enzyme-linked immunosorbent assay (ELISA)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universitäts-Hautklinik Kiel Kiel Schleswig-Holstein Germany 24105

Sponsors and Collaborators

  • Dr. August Wolff GmbH & Co. KG Arzneimittel

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier:
NCT04538183
Other Study ID Numbers:
  • DK-01/2017
First Posted:
Sep 4, 2020
Last Update Posted:
Sep 4, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 4, 2020