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Testing a Novel Barrier Cream for Fecal Incontinence in an Ambulatory Population

StatusNot Yet Recruiting
PhaseNot applicable
SponsorScotiaderm
Started
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Record History

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  1. Start date: Jan 2026 to Sep 1, 2026
    • Primary completion date: Dec 2026 to Apr 1, 2027
    • Study completion date: Jun 2027 to Nov 1, 2027
    • Study description shortened, about 23 words
    v4
  2. Secondary endpoints revised (3)
    • Study description expanded, about 2 words
    v3
  3. Primary completion date: May 2025 to Dec 2026v2 Show 10 more changesShow less
    • Start date: May 2024 to Jan 2026
    • Primary endpoints: 1 to 2
    • Study sites: 0 to 1
    • Study completion date: May 2026 to Jun 2027
    • Interventions: MASD Control Arm (Other) to Barrier Cream (Other), Dermategrity Everyday Barrier Cream (Other)
    • Eligibility criteria expanded, about 99 words
    • Secondary endpoints: 1 to 3
    • Study description expanded, about 527 words
    • Collaborators expanded, about 3 words
    • Study title shortened, about 1 word
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 and extensive erosion of affected skin. There are no known products on the market that treat fecal incontinence or MASD caused by fecal enzyme activity. Scotiaderm has invented a novel barrier cream (Dermategrity Everyday Barrier Cream) with an enhanced formula containing zinc oxide and a natural plant extract that inhibits fecal enzymes to protect the skin while preventing further breakdown. Dermategrity Everyday Barrier Cream has shown superior outcomes in comparison to zinc oxide alone in simulated laboratory testing, and promising results have been obtained in clinical case studies. To date, however, there has been no formal clinical testing of this new barrier product in comparison to standard zinc oxide creams. The purpose of this study is to perform a randomized, controlled clinical study comparing Dermategrity Everyday Barrier Cream to zinc oxide barrier cream to determine if there is a difference in healing, clinical outcomes, and the speed of resolution of MASD symptoms between groups, in an ambulatory patient population.
Trial Details
NCT Number NCT06370637
Lead Sponsor Scotiaderm
Collaborators: University of Calgary
Conditions
(from sponsor)		 Moisture Associated Skin Damage, Fecal Incontinence, Incontinence Associated Dermatitis
Related terms Fecal Incontinence
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov