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

NCT06221046 | Not Yet Recruiting

• 1 other identifier: CT-DRM-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 "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

Keywords

MASD; Moisture Associated Skin Damage; Incontinence Associated Dermatitis; IAD; Fecal Incontinence

Outcome Measures

Primary Outcomes (3)

• 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 "no visible signs of erythema" to "worst possible erythema", allowing the investigator to capture erythema for all skin colors and types. The VAS Erythema will be performed daily for 7 days, and once again on day 14.

  14 days

• Safety - Adverse Events and Product-Related Adverse Effects

  Safety of the investigational product will be assessed by documenting the frequency and severity of adverse events, and their relationship to the investigational product.

  14 days

Secondary Outcomes (2)

• Trans-epidermal Water Loss (TEWL)

  14 days

• CAN MASD Assessment Tool

  14 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Control (Standard treatment)

Investigational Product

EXPERIMENTAL

Patients in units randomized to the intervention arm will be treated with Scotiaderm's novel barrier cream, Dermategrity "anti-fecal" barrier cream.

Other: Novel Barrier Cream

Interventions

Control (Standard treatment) DRUG

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.

Also known as: Zinc Oxide Barrier Cream

Control

Novel 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.

Also known as: Dermategrity "Anti-fecal" Barrier Cream

Investigational Product

Eligibility Criteria

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

You may not qualify if:

• History of complex skin disorders (such as psoriasis or eczema);
• Allergy to any of the ingredients in the study product;
• Visual evidence of a bacterial skin infection;
• Anticipated length of stay in hospital less than two weeks;
• Life expectancy less than two weeks;
• Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care.
• Note: 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.

Sponsors & Collaborators

• Scotiaderm: lead
• The Salvation Army Toronto Grace Health Centre: collaborator

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

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

Study Officials

• Kevin Woo, PhD, RN, NSWOC WOCC(C)

  Toronto Grace Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devan Pancura, MSc

CONTACT

902-233-534; Devan@scotiaderm.com

Johanna Mercer, BA, MFA

CONTACT

902-698-8373; Johanna@scotiaderm.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 performed by unit, such that each participating unit provides the same treatment to all patients within that unit. This minimizes error in the supply chain of study product. 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 separate in the shipping container. The study coordinator will ensure that each participating unit receives the correct product (study intervention or control).
• 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 60 patients in medical units at Toronto Grace Health Centre who present with IAD from diarrhea and/or fecal incontinence. Randomizations will be done by medical unit. Patients will be enrolled in each participating unit until 30 patients are recruited in each study arm.

Study Record Dates

• First Submitted: January 14, 2024
• First Posted: January 24, 2024
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share