IncontinenceNCT06248255
Impact on Elderly Skin Due to Wet Pad Application.
A study testing Pads in people with Incontinence, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial summary
The clinical study aims to measure the changes in the stratum corneum on older healthy participants due to the application of a wet pad on the forearm. Participants are subject to baseline measures of TransEpidermalWaterLoss (TEWL), skin hydration (SH), pH and water profile (raman spectroscopy). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incontinence
- What is being tested?
- Pads
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- 14 Dec 2023to 28 Feb 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women ≥ 65 years.
- Mentally and physically able to participate in this study.
- Written informed consent to participate in this study.
- Intact skin on the volar forearms without skin irritation.
Who cannot join
- Have any known allergies or intolerances to one or several components of the absorbing incontinence product.
- Suffer from excessive sweating, hyperhidrosis.
- Have any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
- Not be of childbearing potential.
- Have an alcohol and/or drug dependency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact to Skin Due to Wet Pad Application. Skin Status and Change in the Stratum Corneum as Measured With 4 Instruments in an Elderly Population.
The clinical study aims to measure the changes in the stratum corneum on older healthy participants due to the application of a wet pad on the forearm. Participants are subject to baseline measures of TransEpidermalWaterLoss (TEWL), skin hydration (SH), pH and water profile (raman spectroscopy). Dry or wet pads are then added to the skin and worn for two hours. After a recovery period, the SkinSurfaceWaterLoss (SSWL) and skin hydration and water profile is measured. The study is conducted over a single visit. Pads on the arms consist of incontinence product cutouts and are loaded to 50% or 100% capacity. The endpoints are the changes in stratum corneum as measured by the instruments during the visit.
- Conditions
- Incontinence
- Being tested
- Pads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PadsOther
Single arm design in which each participant act as its own control. Wet or Dry pads are applied to the participants forearms.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Single arm study, all participants get pads applied to their forearms Receives: Other: Pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Trans Epidermal Water loss
As measured by Dermalab instrument. Transepidermal water loss (TEWL) from dry skin and the subsequent skin surface water loss (SSWL) from wet skin
Measured: 2 hours
Change in skin hydration
Skin hydration (SH) as measured with moisturemeter instrument
Measured: 2 hours
Change in Skin water profile
As measured Confocal raman microspectometry. The water content of skin at different depths.
Measured: 2 hours
Secondary outcomes (1)
Change in skin surface pH
Skin surface pH measurement using pH meter
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start14 Dec 2023
- Primary completion9 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IncontinenceStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The test pads is to both forearms of the participants. Participants will be blinded to the test pad type. In total 4 pads are applied per participant. The test pads are either Dry (control), 50% or at 100% capacity. Dry and 50% pads are applied once, 100% capacity twice. This to allow one pad for recovery measurement and one for water profile measurement. Pad location will be randomized.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shabira Abbas, PhD, Principal investigator, Essity Hygiene and Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248255
- Sponsor's protocol ID
- DROPBOX
- Status last verified
- Mar 2024
- First submitted
- 31 Jan 2024
- Last updated
- 15 Mar 2024
- 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact to Skin Due to Wet Pad Application. Skin Status and Change in the Stratum Corneum as Measured With 4 Instruments in an Elderly Population.
- ClinicalTrials.gov ID
- NCT06248255
- Acronym / sponsor ID
- DROPBOX
- Conditions
- Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 8 Feb 2024 (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 clinical study aims to measure the changes in the stratum corneum on older healthy participants due to the application of a wet pad on the forearm. Participants are subject to baseline measures of TransEpidermalWaterLoss (TEWL), skin hydration (SH), pH and water profile (raman spectroscopy). Dry or wet pads are then added to the skin and worn for two hours. After a recovery period, the SkinSurfaceWaterLoss (SSWL) and skin hydration and water profile is measured. The study is conducted over a single visit. Pads on the arms consist of incontinence product cutouts and are loaded to 50% or 100% capacity. The endpoints are the changes in stratum corneum as measured by the instruments during the visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The test pads is to both forearms of the participants. Participants will be blinded to the test pad type. In total 4 pads are applied per participant. The test pads are either Dry (control), 50% or at 100% capacity. Dry and 50% pads are applied once, 100% capacity twice. This to allow one pad for recovery measurement and one for water profile measurement. Pad location will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: PadsSingle arm study, all participants get pads applied to their forearms |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Men and women ≥ 65 years.
- Mentally and physically able to participate in this study.
- Written informed consent to participate in this study.
- Intact skin on the volar forearms without skin irritation.
Key exclusion criteria (5 listed)
- Have any known allergies or intolerances to one or several components of the absorbing incontinence product.
- Suffer from excessive sweating, hyperhidrosis.
- Have any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
- Not be of childbearing potential.
- Have an alcohol and/or drug dependency.
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 |
|---|---|---|
| PadsSingle arm design in which each participant act as its own control. Wet or Dry pads are applied to the participants forearms. | Other | Intervention arm |
Primary outcome
Change Trans Epidermal Water loss
Time frame: 2 hours
As measured by Dermalab instrument. Transepidermal water loss (TEWL) from dry skin and the subsequent skin surface water loss (SSWL) from wet skin
Change in skin hydration
Time frame: 2 hours
Skin hydration (SH) as measured with moisturemeter instrument
Change in Skin water profile
Time frame: 2 hours
As measured Confocal raman microspectometry. The water content of skin at different depths.
1 secondary outcome
Change in skin surface pH
Time frame: 2 hours
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 15 Mar 2024.
- 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.
Shabira Abbas, PhD principal investigator
Essity Hygiene and Health AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pads in people with Incontinence, run by Essity Hygiene and Health AB at 1 site in Sweden.
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 5 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 15 Mar 2024. 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 Sweden. 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 Trans Epidermal Water loss (time frame: 2 hours). The study lists 3 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 15 Mar 2024.