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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

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 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.

Eligibility

Primary outcome measure(s)

• GLOB-IAD Clinical Assessment — 14 days
  The GLOB-IAD Clinical Assessment is the only validated clinical tool for assessing MASD. This assessment will be performed daily for the first 7 days, and once again at day 14. All GLOB-IAD assessments will be done by a qualified study team member (i.e., principle investigator, wound care nurse, etc.).
• Visual Analog Scale for Erythema — 14 Days
  The Visual Analog Scale (VAS) for erythema is a visual assessment tool to measure the severity of a patient's erythema. The VAS Erythema employs a visual scale from 0 "no visible signs of erythema" to 100 "worst possible erythema", allowing the investigator to capture erythema for all skin colors and types. The VAS Erythema will be performed at baseline, day 7, and day 14.

Trial sites (1)

Other trials for the same condition