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

ConditionsMoisture Associated Skin DamageIncontinence Associated DermatitisFecal Incontinence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorScotiaderm

About this trial

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 a natural plant 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age;

Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and/or fecal incontinence;

Minimum expected stay in hospital of two weeks;

Able to provide written informed consent (OR consent by a recognized substitute-decision maker) including explicit consent to take daily photographs of the rash associated with MASD.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Novel Barrier Cream

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: Investigational ProductExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.).

Time frame
14 days
2

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.

Time frame
14 days
3

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.

Time frame
14 days

Secondary outcomes

1

Trans-epidermal Water Loss (TEWL)

Increased loss of water through the epidermis is indicitive of reduced integrity of the skin;s natural barrier. Trans-epidermal water loss from the area affected by MASD will be measured using a TEWL probe (Tewameter TM Hex Probe). TEWL will be measured daily for 7 days, and once again on day 14.

Time frame
14 days
2

CAN MASD Assessment Tool

The CAN MASD is a novel assessment tool for MASD. This study will test the reliability and validity of the CAN MASD for assessing MASD in a clinical setting, compared to the only other validated assessment tool for IAD, the GLOB-IAD. CAN MASD Assessments will be performed daily for 7 days, and once again on day 14.

Time frame
14 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Scotiaderm

Lead sponsor

The Salvation Army Toronto Grace Health Centre

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: