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

NCT06221046 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-15

No results posted yet for this study

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 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 soybean 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.

Conditions

  • Moisture Associated Skin Damage
  • Incontinence Associated Dermatitis
  • Fecal Incontinence

Interventions

DRUG

Control (Standard treatment)

Patients in the control arm will be treated with a standard zinc oxide barrier cream. Scotiaderm will supply the control product, such that the formula is identical to the intervention with the only difference being the addition of plant extract in the investigational product.

OTHER

Novel Barrier Cream

Patients randomized to the intervention arm will receive treatment with Scotiaderm's proprietary barrier cream formula. This product contains soy extract for enhanced healing of MASD secondary to fecal incontinence.

Sponsors & Collaborators

  • The Salvation Army Toronto Grace Health Centre

    collaborator UNKNOWN

  • Scotiaderm

    lead OTHER

Principal Investigators

  • Kevin Woo, PhD, RN, NSWOC WOCC(C) · Toronto Grace Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-08-01
Completion
2026-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06221046 on ClinicalTrials.gov