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

NCT06370637 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-09-03

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 Everyday 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 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.

Conditions

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

Interventions

OTHER

Barrier Cream

Patients in the control arm will be treated with a 15% 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

Dermategrity Everyday 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

  • University of Calgary Cumming School of Medicine

    collaborator UNKNOWN

  • Scotiaderm

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Canada

Study Locations

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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 NCT06370637 on ClinicalTrials.gov