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New cream with plant extract aims to heal Incontinence-Related skin damage

NCT ID NCT06221046

Symptom relief Sponsor: Scotiaderm Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 7 times

Summary

This study tests a new barrier cream (Dermategrity "Anti-fecal" Barrier Cream) that contains zinc oxide and a natural plant extract to protect and heal skin damaged by incontinence. Sixty adults with incontinence-associated dermatitis will receive either the new cream or a standard zinc oxide cream. Researchers will compare healing, redness, and skin barrier function over 14 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
barrier cream with zinc oxide and soy extract
What this could lead to
If it works, this could offer a more effective cream for healing skin damaged by incontinence, reducing pain and improving quality of life.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to everyone. The cream is not yet proven to work better than standard treatments.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Patients who meet all the below criteria will be eligible for inclusion in the study: * ≥18 years of age; * Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and/or fecal incontinence; * Minimum expected stay in hospital of two weeks; * Able to provide written informed consent (OR consent by a recognized substitute-decision maker) including explicit consent to take daily photographs of the rash associated with MASD. Patients who meet any of the following exclusion criteria will not be eligible for enrolment: * History of complex skin disorders (such as psoriasis or eczema); * Allergy to any of the ingredients in the study product; * Visual evidence of a bacterial skin infection; * Anticipated length of stay in hospital less than two weeks; * Life expectancy less than two weeks; * Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care. Note: Patients who are pregnant will not be excluded from the study unless they present with a rash or other skin conditions that may confound assessments.

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Conditions

The condition(s) this trial relates to.

Fecal Incontinence irritant dermatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fecal incontinence Incontinence-associated dermatitis Moisture associated skin damage

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.