Status:
NOT_YET_RECRUITING
Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage
Lead Sponsor:
Scotiaderm
Collaborating Sponsors:
The Salvation Army Toronto Grace Health Centre
Conditions:
Moisture Associated Skin Damage
Incontinence Associated Dermatitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Liquid stool and diarrhea are associated with an increased risk for moisture-associated skin damage (MASD), and clinical evidence suggests that exposure to liquid stool is associated with severe MASD ...
Detailed Description
Moisture associated skin damage (MASD) is a grouping of painful, irritating rashes which occur when a patient has repeated or prolonged exposure to moisture from perspiration, urine and/or feces. Comm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06221046
Start Date
August 1 2025
End Date
November 1 2026
Last Update
May 15 2025
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