Barrier Cream for Fecal Incontinence

(Survey Trial)

Overseen By Devan Pancura, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scotiaderm

Disqualifiers: Psoriasis, Eczema, Bacterial infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new barrier cream, Dermategrity Everyday Barrier Cream, to determine if it better protects and heals skin damaged by fecal incontinence compared to a standard zinc oxide cream. The study aims to assess whether the new cream improves healing, clinical outcomes, and recovery speed. Individuals with skin irritation from diarrhea or fecal incontinence who can apply the cream themselves or with assistance may be eligible to join. As an unphased trial, participants contribute to important research that may lead to improved skin care solutions.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that Dermategrity Everyday Barrier Cream is safe for use in treating MASD?

Research has shown that Dermategrity Everyday Barrier Cream is likely safe based on early studies. In lab tests, it outperformed zinc oxide alone. Clinical case studies have also been positive, suggesting that most people can use the cream without issues.

Studies on similar creams indicate they help keep skin moist and protect it from damage. While this new cream is still undergoing tests, these findings are reassuring about its safety.

Compared to zinc oxide cream, a common and trusted treatment, its safety is likely similar. Individual reactions can vary, but overall, evidence suggests it should be safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for managing fecal incontinence, which typically includes barrier creams like the 15% zinc oxide, Dermategrity Everyday Barrier Cream offers a novel approach. Researchers are excited about this treatment because it might provide enhanced skin protection and comfort, potentially reducing irritation more effectively than traditional options. This could mean better quality of life for patients by minimizing skin damage and discomfort associated with fecal incontinence.

What evidence suggests that Dermategrity Everyday Barrier Cream might be an effective treatment for MASD?

Research has shown that Dermategrity Everyday Barrier Cream, which participants in this trial may receive, may effectively treat skin damage from contact with liquid stool. In lab tests, this cream outperformed zinc oxide alone, a common ingredient in many skin protectants. Case studies suggest it might heal skin faster and reduce symptoms more effectively than current zinc oxide creams. The cream contains zinc oxide and soybean extract, which together protect the skin and prevent further damage by blocking harmful enzymes in stool. Although formal clinical testing against standard treatments is still needed, these early results are promising. Participants in the control arm of this trial will receive a 15% zinc oxide barrier cream, the standard of care for MASD. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who can consent to treatment, self-apply the cream, and are experiencing skin issues due to fecal incontinence or diarrhea. It's not specified who cannot join.

Inclusion Criteria

I am 18 years old or older.

I can apply cream myself or with someone's help.

I have skin irritation due to incontinence or diarrhea.

Exclusion Criteria

I have a history of complex skin conditions like psoriasis or eczema.

I am pregnant but do not have a rash or skin condition that could affect study assessments.

Known allergy to any of the ingredients in the study product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either Dermategrity Everyday Barrier Cream or standard zinc oxide barrier cream for the treatment of MASD

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dermategrity Everyday Barrier Cream

Trial Overview The study tests Dermategrity Everyday Barrier Cream against standard zinc oxide creams to see if it better heals and resolves symptoms of skin damage caused by moisture from fecal incontinence.

How Is the Trial Designed?

Group I: Investigational Product Experimental Treatment 1 Intervention

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

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Scotiaderm

Lead Sponsor

Trials

3

Recruited

90+

University of Calgary Cumming School of Medicine

Collaborator

Trials

2

Recruited

1,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06370637

Testing a Novel Barrier Cream for Fecal Incontinence in an ... Dermategrity Everyday Barrier Cream has shown superior outcomes in comparison to zinc oxide alone in simulated laboratory testing, and promising results have ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06221046

Testing the Safety and Efficacy of a Novel Barrier Cream for ... 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 ...

3. withpower.com withpower.com/trial/phase-incontinence-associated-dermatitis-4-2024-d3b0c

Barrier Cream for Fecal Incontinence (Survey Trial) Trial Overview The study tests Dermategrity Everyday Barrier Cream against standard zinc oxide creams to see if it better heals and resolves symptoms of skin ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5344181/

Clinical Evaluation of a Skin Protectant for the Management of ... The novel skin protectant evaluated in this study led to a significant reduction in IAD scores and IAD-associated pain scores during cleansing ...

5. researchgate.net researchgate.net/publication/318515468_Effects_of_a_Skin_Barrier_Cream_on_Management_of_Incontinence-Associated_Dermatitis_in_Older_Women_A_Cluster_Randomized_Controlled_Trial

Effects of a Skin Barrier Cream on Management ... The results of studies conducted on patients with incontinence-associated dermatitis showed that barrier cream contributed to protecting the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28723852/

Effects of a Skin Barrier Cream on Management ... Study findings suggest that a barrier cream designed to enhance the skin's moisture barrier and act as a skin protectant increased stratum corneum hydration ...