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Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage

StatusNot Yet Recruiting
PhaseNot applicable
SponsorScotiaderm
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv9
  2. Minor Study description expanded, about 1 wordv8
  3. Minor Study description shortened, about 2 wordsv7
  4. Minor Study description expanded, about 2 wordsv6
  5. Notable Primary completion date: Aug 1, 2026 to Apr 1, 2027
    • Start date: Aug 1, 2025 to Aug 31, 2026
    • Study completion date: Nov 1, 2026 to Aug 1, 2027
    v5
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  1. Notable Enrollment target: 30 to 60v4 Show 10 more changesShow less
    • Primary completion date: Jun 1, 2025 to Aug 1, 2026
    • Start date: Jun 1, 2024 to Aug 1, 2025
    • Primary endpoints: 1 to 3
    • Study completion date: Jun 1, 2025 to Nov 1, 2026
    • Interventions: Control (Other), Cream D (Other) to Control (Standard treatment) (Drug), Novel Barrier Cream (Other)
    • Eligibility criteria expanded, about 71 words
    • Secondary endpoints expanded, about 8 words
    • Study description expanded, about 928 words
    • Collaborators expanded, about 7 words
    • Study title expanded, about 14 words
  2. Notable Start date: Apr 1, 2024 to Jun 1, 2024
    • Primary and study completion dates: Apr 1, 2025 to Jun 1, 2025
    • Study description shortened, about 8 words
    v3
  3. Minor Eligibility criteria shortened, about 27 words
    • Study description expanded, about 1 word
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 "Anti-fecal" 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 "Anti-fecal" 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 "Anti-fecal" 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.
Trial Details
NCT Number NCT06221046
Lead Sponsor Scotiaderm
Collaborators: The Salvation Army Toronto Grace Health Centre
Conditions
(from sponsor)
Moisture Associated Skin Damage, Incontinence Associated Dermatitis, Fecal Incontinence
Related terms Fecal Incontinence
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov