Incontinence-associated DermatitisDROPBOXNCT07164898
How Wet Pads Affect Elderly Skin: Measuring Changes in the Skin Barrier
A study testing Test patches in people with Incontinence-associated Dermatitis, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial summary
The main aim of this study is to describe the effects of dry or wet incontinence pad material on the skin barrier function by measuring the changes of the stratum corneum on healthy participants due to the application of pads with varying wetness level to the forearm. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Incontinence-associated Dermatitis
- What is being tested?
- Test patches
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 13 Dec 2023to 30 Apr 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 main aim of this study is to describe the effects of dry or wet incontinence pad material on the skin barrier function by measuring the changes of the stratum corneum on healthy participants due to the application of pads with varying wetness level to the forearm. Study findings have relevance for product development of absorbing incontinence products to further protect the skin from the damaging effects of excess moisture. Participants are subject to baseline measures of TEWL, SH, pH and water profile. Dry or wet pads are then added to the forearm skin and worn for two hours. After a recovery period, the SSWL, SH and water profile is measured. The study is conducted over a single 4h visit. As this is an explorative study no hypothesis is intended to be tested.
- Conditions
- Incontinence-associated Dermatitis
- Being tested
- Test patches
- Keywords
- "skin barrier" "absorbing incontinence product" elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test patchesDevice
Patches (incontinence product cut outs) either dry, 50% saturated with water or 100% saturated with water applied to the forearm and worn for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Test patches | Experimental | Application of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula. Receives: Device: Test patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Trans Epidermal Water loss (TEWL)
TEWL is measured at baseline and then after 2h of dry patch use the unit is g/m2*h. For the wet patches the follow up measurement is on skin surface water loss (SSWL) as the skin is not dry the unit is the same as for TEWL.
Measured: 2 hours
Secondary outcomes (3)
Change in skin hydration
Skin hydration (SH) as measured with moisture meter instrument under the test and control patches. Measure in arbitrary units (a.u).
Measured: 2 hours
Change in skin surface pH
The pH change under the dry/wet patches are measured and compared.
Measured: 2 hours
Change skin water profile
As measured Confocal raman microspectrometry. The water content (mass-% water) of skin at different depths is measured and compared for the skin under wet/dry patches.
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 posted10 Sep 2025
- Study start13 Dec 2023
- Primary completion9 Feb 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence-associated DermatitisStudies 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
- Healthy volunteers get dry or wet test patches applied to the skin of the forearms. The cut outs are either dry or wetted with saline to 50% or 100% capacity. In total two pads are applied per forearm.
- Masking
- None (open label)
- Enrolment
- 25 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 & Health AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164898
- Sponsor's protocol ID
- C3197
- Acronym
- DROPBOX
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 10 Sep 2025
- 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 10 Sep 2025. 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
- NCT07164898
- Acronym / sponsor ID
- DROPBOX / C3197
- Conditions
- Incontinence-associated Dermatitis
- Keywords
- "skin barrier" "absorbing incontinence product" elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 9 Feb 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Sep 2025 (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 main aim of this study is to describe the effects of dry or wet incontinence pad material on the skin barrier function by measuring the changes of the stratum corneum on healthy participants due to the application of pads with varying wetness level to the forearm. Study findings have relevance for product development of absorbing incontinence products to further protect the skin from the damaging effects of excess moisture. Participants are subject to baseline measures of TEWL, SH, pH and water profile. Dry or wet pads are then added to the forearm skin and worn for two hours. After a recovery period, the SSWL, SH and water profile is measured. The study is conducted over a single 4h visit. As this is an explorative study no hypothesis is intended to be tested.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy volunteers get dry or wet test patches applied to the skin of the forearms. The cut outs are either dry or wetted with saline to 50% or 100% capacity. In total two pads are applied per forearm.
| Arm | Type | Receives |
|---|---|---|
| Test patches | Experimental | Device: Test patchesApplication of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula. |
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 |
|---|---|---|
| Test patchesPatches (incontinence product cut outs) either dry, 50% saturated with water or 100% saturated with water applied to the forearm and worn for 2 hours | Device | Test patches |
Primary outcome
Change in Trans Epidermal Water loss (TEWL)
Time frame: 2 hours
TEWL is measured at baseline and then after 2h of dry patch use the unit is g/m2*h. For the wet patches the follow up measurement is on skin surface water loss (SSWL) as the skin is not dry the unit is the same as for TEWL.
3 secondary outcomes
Change in skin hydration
Time frame: 2 hours
Change in skin surface pH
Time frame: 2 hours
Change skin water profile
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 10 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Incontinence-associated Dermatitis
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Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
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Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
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Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
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Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
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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 & 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 Test patches in people with Incontinence-associated Dermatitis, 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 10 Sep 2025. 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 in Trans Epidermal Water loss (TEWL) (time frame: 2 hours). 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 10 Sep 2025.