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

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.

Inclusion Criteria * ≥18 years of age * Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and/or fecal incontinence. * Able to provide written informed consent * Either able to self-administer barrier cream to the affected region OR administer with the assistance of a caregiver Exclusion Criteria * History of complex skin disorders (such as psoriasis or eczema) * Known allergy to any of the ingredients in the study product * Visual evidence of a bacterial skin infection * Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care. * Patients who are pregnant will not be excluded from the study unless they present with a rash or other skin conditions that may confound assessments * A medical condition that, in the opinion of the investigator, precludes the patient from being able to provide informed consent OR presents confounds which may bias the study outcomes