Aged SkinNCT03629405
Assessment of the Efficacy and Barrier Protection of Two Cosmetic Products
A study testing C - pH 4 Cosmetic Product WO 3741 and D - pH 5.8 Cosmetic Product WO 4081-1 in people with Aged Skin, run by Dr. August Wolff GmbH & Co. KG Arzneimittel at 1 site in Germany.
Trial summary
The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aged Skin
- What is being tested?
- C - pH 4 Cosmetic Product WO 3741 and D - pH 5.8 Cosmetic Product WO 4081-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 11 Aug 2016to 9 Sep 2016
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written Informed Consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female and male (at least 30% male subjects)
- From 50 to 75 years of age, equally distributed
Who cannot join
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS or infectious hepatitis if known to the subjects
- Conditions which exclude a participation or might influence the test reaction/ evaluation
- Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies
- Active skin disease at the test area
- One of the following serious illnesses that might require regular systemic medication: insulin-dependent diabetes
- Moles, tattoos, scars, irritated skin, hairs, etc. at the test area that could influence the Investigation
Trial locations and contacts
1 site in 1 country.
Germany1 site
proDERM Institute for Applied Dermatological Research
Schenefeld
About this study
Official title: Assessment of the Long-Term Efficacy and Barrier Protection of Two Skin Care Products
The aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.
- Conditions
- Aged Skin
- Being tested
- C - pH 4 Cosmetic Product WO 3741, D - pH 5.8 Cosmetic Product WO 4081-1
- Keywords
- pH of the skin, SDS, Lipbarvis, TEWL, Skin hydration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C - pH 4 Cosmetic Product WO 3741Other
Application of the product on the pre-defined skin area on the forearms twice daily for four weeks
D - pH 5.8 Cosmetic Product WO 4081-1Other
Application of the product on the pre-defined skin area on the forearms twice daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| A - Negative control (untreated) for product C | No intervention | On the forearms four test areas were located, which were labeled from A-D. Test area A contralateral to product C |
| B - Negative control (untreated) for product D | No intervention | On the forearms four test areas were located, which were labeled from A-D. Test area B contralateral to product D |
| C - Cosmetic Product WO 3741 with pH 4 | Experimental | On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D. Receives: Other: C - pH 4 Cosmetic Product WO 3741 |
| D - Cosmetic Product WO 4081-1 with pH 5.8 | Experimental | On the forearms four test areas were located, which were labeled from A-D. Receives: Other: D - pH 5.8 Cosmetic Product WO 4081-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin pH
Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter
Measured: baseline, Day 29, Day 30
Secondary outcomes (4)
Transepidermal Water Loss
Change from baseline at Day 29 and Day 30 of Transepidermal Water Loss (g/m2/h) assessed by Tewameter
Measured: baseline, Day 29, Day 30
Skin Hydration
Change from baseline at Day 29 and Day 30 of Skin Hydration Arbitrary Units assessed by Corneometer
Measured: baseline, Day 29, Day 30
Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS)
Change from baseline at Day 29 and Day 30 of stratum corneum assessed by transmission electron microscopy
Measured: baseline, Day 29, Day 30
Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide))
Change from baseline at Day 29 and Day 30 of corneocyte layer area assessed from the TEM data
Measured: baseline, Day 29, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start11 Aug 2016
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aged SkinStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH, Microscopy Services Dähnhardt GmbH
- Responsible party
- Sponsor
- Investigators
- Prof. Klaus-Peter Wilhelm, MD, Study director, proDERM Institute for Applied Dermatological Research, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629405
- Sponsor's protocol ID
- PH4G-04/2016
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Long-Term Efficacy and Barrier Protection of Two Skin Care Products
- ClinicalTrials.gov ID
- NCT03629405
- Acronym / sponsor ID
- PH4G-04/2016
- Conditions
- Aged Skin
- Keywords
- pH of the skin, SDS, Lipbarvis, TEWL, Skin hydration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr. August Wolff GmbH & Co. KG ArzneimittelIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH, Microscopy Services Dähnhardt GmbH
- Study start
- 11 Aug 2016 (actual)
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 14 Aug 2018 (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 aim of the study was to assess the long-term efficacy and barrier protection properties of two cosmetic products on the volar forearms of 20 elderly subjects after four weeks of treatment compared to two untreated test areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - Negative control (untreated) for product C | No intervention | –On the forearms four test areas were located, which were labeled from A-D. Test area A contralateral to product C |
| B - Negative control (untreated) for product D | No intervention | –On the forearms four test areas were located, which were labeled from A-D. Test area B contralateral to product D |
| C - Cosmetic Product WO 3741 with pH 4 | Experimental | Other: C - pH 4 Cosmetic Product WO 3741On the forearms four test areas were located, which were labeled from A-D. Test area C on the same arm like product D. |
| D - Cosmetic Product WO 4081-1 with pH 5.8 | Experimental | Other: D - pH 5.8 Cosmetic Product WO 4081-1On the forearms four test areas were located, which were labeled from A-D. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written Informed Consent to participate in the study
- Willingness to actively participate in the study and to come to the scheduled visits
- Female and male (at least 30% male subjects)
- From 50 to 75 years of age, equally distributed
Key exclusion criteria (8 listed)
- Female subjects: Pregnancy or lactation
- Drug addicts, alcoholics
- AIDS or infectious hepatitis if known to the subjects
- Conditions which exclude a participation or might influence the test reaction/ evaluation
- Participation or being in the waiting period after participation in similar cosmetic and/or pharmaceutical studies
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 |
|---|---|---|
| C - pH 4 Cosmetic Product WO 3741Application of the product on the pre-defined skin area on the forearms twice daily for four weeks | Other | C - Cosmetic Product WO 3741 with pH 4 |
| D - pH 5.8 Cosmetic Product WO 4081-1Application of the product on the pre-defined skin area on the forearms twice daily for four weeks | Other | D - Cosmetic Product WO 4081-1 with pH 5.8 |
Primary outcome
Skin pH
Time frame: baseline, Day 29, Day 30
Change from baseline at Day 29 and Day 30 of Skin pH Units assessed by pH-meter
4 secondary outcomes
Transepidermal Water Loss
Time frame: baseline, Day 29, Day 30
Skin Hydration
Time frame: baseline, Day 29, Day 30
Intercellular lipid lamellae lenght (nm ICLL/1000 nm2 ICS)
Time frame: baseline, Day 29, Day 30
Lipid Analysis ((concentration of : Cholesterol (µg/slide), FFA (µg/slide), Ceramide EOS (µg/slide), Ceramide NP (µg/slide), Ceramide NH (µg/slide))
Time frame: baseline, Day 29, Day 30
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 14 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Prof. Klaus-Peter Wilhelm, MD study director
proDERM Institute for Applied Dermatological Research, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C - pH 4 Cosmetic Product WO 3741 and D - pH 5.8 Cosmetic Product WO 4081-1 in people with Aged Skin, 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 8 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 14 Aug 2018. 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?
Skin pH (time frame: baseline, Day 29, Day 30). 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 14 Aug 2018.