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

NCT06370637 | Not Yet Recruiting

• 1 other identifier: CT-DRM-004
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MASD; Moisture Associated Skin Damage; IAD; Incontinence Associated Dermatitis; Fecal Incontinence; Dermategrity; Barrier Cream

Outcome Measures

Primary Outcomes (2)

• GLOB-IAD Clinical Assessment

  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.).

  14 days

• Visual Analog Scale for Erythema

  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.

  14 Days

Secondary Outcomes (3)

• Safety - Adverse Events and Product-Related Adverse Effects

  14 Days

• Patient-reported Satisfaction

  14 Days

• Visual Analog Scale - Symptoms

  14 Days

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients randomized to the control arm will be treated with a 15% zinc oxide barrier cream, which is standard of care for MASD.

Other: Barrier Cream

Investigational Product

EXPERIMENTAL

Patients randomized to the intervention arm will be treated with Dermategrity Everyday Barrier Cream.

Other: Dermategrity Everyday Barrier Cream

Interventions

Barrier Cream OTHER

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.

Control

Dermategrity Everyday Barrier Cream OTHER

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.

Investigational Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scotiaderm: lead
• University of Calgary Cumming School of Medicine: collaborator

Study Sites (1)

University of Calgary Cumming School of Medicine

Calgary, Alberta, T2N 2T8, Canada

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Devan Pancura, MSc

CONTACT

(902)233-7534; Devan@scotiaderm.com

Ann Gordon, MD

CONTACT

902-698-8372; dctrakg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomizations will be assigned by placing an equal number of control and intervention assignments into opaque envelopes. When a patient is enrolled, the research coordinator will draw an envelope, and the assignment in that envelope will be given to that patient. This process will be repeated for all patients enrolled. Patients will be enrolled until 20 patients are recruited in each study arm. The research coordinator will have a list of the randomizations; this will not be shared with the investigator, the care team, or the participants. Study product will be provided in identical, plain white tubes with labels of arm 1 (control) and arm 2 (intervention). The study coordinator will ensure that participants receive the correct product for their randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, randomized, double-blind, controlled study. This study will follow 40 patients from the wound clinic at the University of Calgary who present with IAD from diarrhea and/or fecal incontinence. Randomizations will be performed at a 1:1 ratio, with 20 patients randomized to the control arm, and 20 patients randomized to the intervention arm.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: April 17, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)