Incontinence-associated DermatitisBioSensNCT07816549
Prospective Explorative Research Study of Comparison of Biomarkers Related to Incontinence Associated Dermatitis (IAD) From Skin Swabs
An observational study of Incontinence-associated Dermatitis, run by Essity Hygiene and Health AB at 1 site in Sweden.
Trial summary
The aim of this explorative study is to collect information about biomarkers that differentiate skin affected by Incontinence Associated Dermatitis (IAD) from non-affected skin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incontinence-associated Dermatitis
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2025to 13 Nov 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is individuals with incontinence that wear an absorbing incontinence product and has the signs of incontinence associated dermatitis (IAD).
Who may be able to join
- Age ≥ 18 years.
- Mentally and physically able to participate in this study.
- Willing and able to provide written informed consent to participate in this study or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the participant.
- Individual with urinary and/or faecal incontinence and using incontinence products at a regular basis.
- Has an area under incontinence products with IAD, incontinence associated dermatitis that shows any sign(s) of skin irritation e.g., redness, itching, rashes. 1A and 2A according to GLOBIAD categorisation model [Appendix C for detailed description]. 1A is persistent redness without clinical sign of infection and 2A is skin loss without clinical sign of infection.
Who cannot join
- Severe skin breakdown at the investigated area.
- Individual with skin infection at the investigated area.
- GLOBIAD 1B and 2B, 1B is persistent redness with clinical signs of infection and 2B is skin loss with clinical sign of infection
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this explorative study is to collect information about biomarkers that differentiate skin affected by Incontinence Associated Dermatitis (IAD) from non-affected skin.
Read the detailed description
The findings obtained from this study will be used to develop biosensors that aims to predict the increasing risk of developing IAD and hence be able to prevent the occurrence of IAD.
- Conditions
- Incontinence-associated Dermatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Identified biomarkers level
Measured: One time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Feb 2025
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essity Hygiene and Health AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816549
- Sponsor's protocol ID
- BioSens
- Acronym
- BioSens
- Status last verified
- Sep 2025
- First submitted
- 23 Jan 2025
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Explorative Research Study of Comparison of Biomarkers Related to Incontinence Associated Dermatitis (IAD) From Skin Swabs
- ClinicalTrials.gov ID
- NCT07816549
- Acronym / sponsor ID
- BioSens / BioSens
- Conditions
- Incontinence-associated Dermatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Essity Hygiene and Health ABIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 11 Sep 2026 (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 this explorative study is to collect information about biomarkers that differentiate skin affected by Incontinence Associated Dermatitis (IAD) from non-affected skin.
Detailed description
The findings obtained from this study will be used to develop biosensors that aims to predict the increasing risk of developing IAD and hence be able to prevent the occurrence of IAD.
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is individuals with incontinence that wear an absorbing incontinence product and has the signs of incontinence associated dermatitis (IAD).
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Mentally and physically able to participate in this study.
- Willing and able to provide written informed consent to participate in this study or, if unable to provide such consent, have a legal representative who is willing and able to provide informed consent on behalf of the participant.
- Individual with urinary and/or faecal incontinence and using incontinence products at a regular basis.
- Has an area under incontinence products with IAD, incontinence associated dermatitis that shows any sign(s) of skin irritation e.g., redness, itching, rashes. 1A and 2A according to GLOBIAD categorisation model [Appendix C for detailed description]. 1A is persistent redness without clinical sign of infection and 2A is skin loss without clinical sign of infection.
Key exclusion criteria (3 listed)
- Severe skin breakdown at the investigated area.
- Individual with skin infection at the investigated area.
- GLOBIAD 1B and 2B, 1B is persistent redness with clinical signs of infection and 2B is skin loss with clinical sign of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identified biomarkers level
Time frame: One time
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 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Incontinence-associated Dermatitis
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Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population
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Prevention of Incontinence-associated Dermatitis and Maintenance of Local Skin Microclimate：A Multicenter Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 5 inclusion and 3 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 11 Sep 2026. 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?
Identified biomarkers level (time frame: One time). 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 11 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.