Can a balm shield skin from Incontinence-Related irritation?
NCT ID NCT06924502
First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time
Summary
This study tests whether a protective balm can help care for and protect the skin of people aged 70 and older who have urinary or fecal incontinence and use incontinence products. Participants will have the balm applied to their skin, and doctors, nurses, and patients will rate skin tolerability, skin condition, and product characteristics. The goal is to see if the balm keeps skin healthy and comfortable in this vulnerable population.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A protective balm (water-in-oil emulsion) applied to the skin
- What this could lead to
- If it works, this balm could offer a simple way to keep skin healthy and comfortable for people who rely on incontinence products.
- What could go wrong
- This is a small, early exploratory study without a control group, so results may not be conclusive. The balm may not improve skin condition for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
33 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
-
Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
70 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient is capable of understanding the information given to them and providing informed consent * 70 years of age and older * Patients with incontinence (fecal and/or urinary), requiring incontinence protection material * Skin type on Fitzpatrick scale: Between I to IV Exclusion Criteria: * Current cancer treatment such as chemotherapy, irradiation * Documented allergies to skin care and / or skin cleansing products * Wounds, moles, tattoos, scars, irritated skin, excessive hair growth, etc. at the test area that could influence the investigation * Incontinence-associated dermatitis (IAD) stage \>1a * Active skin disease at the test area * Any topical medication at the test area within the last 3 days prior to the start of the study and / or hroughout te entire course of the study * Mini-Mental-Status-Test (MMST) \< 20
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Klinikum Dortmund
Dortmund, 33137, Germany
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