Health TrialsbyHealthPanel

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

ConditionsMoisture Associated Skin DamageFecal IncontinenceIncontinence Associated Dermatitis
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 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 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.

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Barrier Cream

    Other intervention

    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

    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

40 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 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.

Time frame
14 Days

Secondary outcomes

1

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
2

Patient-reported Satisfaction

On the last visit of the study, patients will be asked to fill out a questionnaire on their satisfaction with the cream used and their opinion on how effective it was at relieving symptoms and treating their rash. The satisfaction questionnaire consists of 4 sections; experience in the trial, satisfaction with the product, comparison to other products, and open feedback.

Time frame
14 Days
3

Visual Analog Scale - Symptoms

The Visual Analog Scale (VAS) for symptoms is a visual assessment tool to measure the severity of a patient's symptoms of pain, itching and burning. The VAS Erythema employs a visual scale from 0 "no feelings of symptom" to 100 "worst possible symptom", allowing a nominal value to be assigned. Three VAS questions will be performed daily - for pain, burning and itching of the rash - for the duration of the study.

Time frame
14 Days

Other outcomes

Sponsors and contacts

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

Scotiaderm

Lead sponsor

University of Calgary

Collaborator

Source ClinicalTrials.gov

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