HealthyNCT04538183
Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
A study testing WO 5000 and WO 5001 in people with Healthy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- WO 5000 and WO 5001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 4 Dec 2017to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female volunteers (75 % women and 25 % men)
- Aged 18 - 75 years
- Healthy skin
- Informed consent was given
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- WO 5000, WO 5001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WO 5000Other
WO 5000
WO 5001Other
WO 5001
| Study group | Role | What they receive |
|---|---|---|
| WO 5000 | Experimental | Body lotion pH 4 for topical application Receives: Other: WO 5000 |
| WO 5001 | Experimental | Body lotion pH 5.8 for topical application Receives: Other: WO 5001 |
| No product use | No intervention | Untreated control area |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of transepidermal water loss (TEWL)
Tewameter TM300, Courage \& Khazaka, Köln
Measured: Change from day 1 (before application) to day 30
Change of skin hydration
Corneometer CM 825, Courage \& Khazaka, Köln
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 31
Corneocyte size
After staining with Nile Red by immunofluorescence microscopy and digital imaging
Measured: Day 31
Amount of the cytokine IL-1α
Determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 31
Amount of antimicrobial peptide hBD-2
Determined by enzyme-linked immunosorbent assay (ELISA)
Measured: Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start4 Dec 2017
- Primary completion3 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sören Merker, Dr., Study chair, Dr. August Wolff GmbH & Co. KG Arzneimittel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538183
- Sponsor's protocol ID
- DK-01/2017
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Test: Dermowas Body Lotion pH 4 vs. pH 5.8
- ClinicalTrials.gov ID
- NCT04538183
- Acronym / sponsor ID
- DK-01/2017
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 3 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 4 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Exploratory, Randomized, Double-blind (regarding the two test products), Intra-individual comparison
| Arm | Type | Receives |
|---|---|---|
| WO 5000 | Experimental | Other: WO 5000Body lotion pH 4 for topical application |
| WO 5001 | Experimental | Other: WO 5001Body lotion pH 5.8 for topical application |
| No product use | No intervention | –Untreated control area |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female volunteers (75 % women and 25 % men)
- Aged 18 - 75 years
- Healthy skin
- Informed consent was given
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WO 5000WO 5000 | Other | WO 5000 |
| WO 5001WO 5001 | Other | WO 5001 |
Primary outcome
Change of transepidermal water loss (TEWL)
Time frame: Change from day 1 (before application) to day 30
Tewameter TM300, Courage \& Khazaka, Köln
Change of skin hydration
Time frame: Change from day 1 (before application) to day 30
Corneometer CM 825, Courage \& Khazaka, Köln
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
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
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)
Corneocyte size
Time frame: Day 31
After staining with Nile Red by immunofluorescence microscopy and digital imaging
Amount of the cytokine IL-1α
Time frame: Day 31
Determined by enzyme-linked immunosorbent assay (ELISA)
Amount of antimicrobial peptide hBD-2
Time frame: Day 31
Determined by enzyme-linked immunosorbent assay (ELISA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sören Merker, Dr. study chair
Dr. August Wolff GmbH & Co. KG Arzneimittel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WO 5000 and WO 5001 in people with Healthy, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of transepidermal water loss (TEWL) (time frame: Change from day 1 (before application) to day 30). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.