N/A
Completed N=167
Prevention of Incontinence-associated Dermatitis
Incontinence-associated Dermatitis
Source: ClinicalTrials.gov NCT05403762 ↗
Enrolled (actual)
167
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcomePrimary: Incidence of Incontinence-associated Dermatitis (IAD) — 18; 8; 5; 5 Participants
Summary
Incontinence-associated dermatitis (IAD) is an inflammation of the skin caused by prolonged direct contact of the skin with urine and/or stool. Elderly and care-dependent people are often affected by this type of inflammation. Gentle skin cleansing and the use of skin protection products are recommended. Available skin protection products can be categorized into film-forming or lipophilic skin protectants depending on the ingredients and overall composition. There is no evidence about the superiority of one product compared to another regarding skin protection. The overall aim of this study is to compare the effects of two skin protection products compared to an untreated control group. An exploratory trial in elderly nursing home residents and geriatric patients will be conducted.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Incontinence-associated Dermatitis (IAD) |
18; 8; 5; 5; 3; 2 | — |
| SECONDARY Erythema (Instrumental Measurement) |
258; 266; 267; 248; 286; 254 | — |
| SECONDARY Erythema (Visual Inspection) |
7; 6; 5; 1; 1; 0 | — |
| SECONDARY Incidence of Erosion |
2; 0; 0; 0; 1; 0 | — |
| SECONDARY Incidence of Maceration |
3; 5; 0; 1; 2; 0 | — |
| SECONDARY IAD Related Pain |
0.0; 0.0; 0.0; 1.5 | — |
| SECONDARY Incidence of IAD Related Itch |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Presence of Local Intolerances |
0; 0; 0 | — |
| SECONDARY Adverse Events (AEs) and Serious Adverse Events (SAEs) |
0; 0; 0 | — |
| SECONDARY Incidents and Serious Incidents |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Geriatric patients or residents being incontinent of urine and stool
- Expected minimum length of stay of 14 days at the care facility
- Intact skin with no clinical signs of IAD OR
- intact skin with early clinical signs of IAD (IAD category 1A)
- Written informed consent
Exclusion Criteria
- Residents/patients at the end of life
- Residents/Patients with IAD category 1B, 2A, 2B and/or signs of clinical infection in the IAD area
- Any skin condition or wounds (at investigational areas of the skin) requiring additional treatment (e. g. pressure ulcers, intertrigo, infection)
- Known hypersensitivity or allergy to silicones and/or topical leave-on products
- Topical treatments in the IAD area.
Data sourced from ClinicalTrials.gov (NCT05403762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.