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

NCT04538183 | Completed

• 1 other identifier: DK-01/2017
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

WO 5000

EXPERIMENTAL

Body lotion pH 4 for topical application

Other: WO 5000

WO 5001

EXPERIMENTAL

Body lotion pH 5.8 for topical application

Other: WO 5001

No product use

NO INTERVENTION

Untreated control area

Interventions

WO 5000 OTHER

WO 5000

WO 5000

WO 5001 OTHER

WO 5001

WO 5001

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female volunteers (75 % women and 25 % men)
• Aged 18 - 75 years
• Healthy skin
• Informed consent was given

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead

Study Sites (1)

Universitäts-Hautklinik Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Study Officials

• Sören Merker, Dr.

  Dr. August Wolff GmbH & Co. KG Arzneimittel

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 4, 2020
• Study Start: December 4, 2017
• Primary Completion: March 3, 2018
• Study Completion: June 30, 2018
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

DE (1)