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Prospective Explorative Research Study of Comparison of Biomarkers Related to Incontinence Associated Dermatitis (IAD) From Skin Swabs

Prospective Explorative Research Study of Comparison of Biomarkers Related to Incontinence Associated Dermatitis (IAD) From Skin Swabs

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07816549
Acronym
BioSens
Enrollment
10
Registered
2026-09-11
Start date
2025-02-01
Completion date
2025-11-13
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incontinence-associated Dermatitis

Brief 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.

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.

Interventions

None listed

Sponsors

Essity Hygiene and Health AB
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years. 2. Mentally and physically able to participate in this study. 3. 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. 4. Individual with urinary and/or faecal incontinence and using incontinence products at a regular basis. 5. 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.

Exclusion criteria

1. Severe skin breakdown at the investigated area. 2. Individual with skin infection at the investigated area. 3. GLOBIAD 1B and 2B, 1B is persistent redness with clinical signs of infection and 2B is skin loss with clinical sign of infection

Design outcomes

Primary

MeasureTime frame
Identified biomarkers levelOne time

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026