60 Participants NeededMy employer runs this trial

Soothing Beta Cream for Diaper Rash

ET
MD
Overseen ByMarlene Dytoc, MD/PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether adding a special moisturizing cream with β-glucan to routine care can heal diaper rash caused by incontinence more quickly and comfortably. Researchers aim to determine if this cream can reduce symptoms like pain and itching and assess its safety. Participants will either use the Soothing Beta Cream (a β-glucan cream) with standard care or receive standard care alone. This trial suits adults with diaper rash due to incontinence who are hospitalized for 7 days or more. As an unphased trial, it offers a unique opportunity to contribute to understanding new treatment options for diaper rash.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that the β-glucan cream is safe for use in this trial?

Research has shown that Soothing Beta Cream, containing beta-glucan, is generally safe and easy to use. Studies have found that this cream, often used for skin irritation, is very safe. It is gentle enough for everyone, including pregnant women, and effectively manages skin irritation.

In one study, participants used a similar beta-glucan cream for 28 days and reported that their skin tolerated it well. Most people did not experience adverse reactions with regular use. These results suggest that Soothing Beta Cream is likely safe for diaper rash and other skin irritations.

While the current trial will provide more information, existing research supports the cream's safety. Based on past experiences with similar products, participants can expect few, if any, side effects.12345

Why are researchers excited about this trial?

Unlike the standard treatments for diaper rash, which typically include barrier creams and ointments like zinc oxide or petroleum jelly, Soothing Beta Cream offers a unique approach by incorporating 0.5% β-glucan as an active ingredient. β-glucan is known for its potential skin-soothing and anti-inflammatory properties, which could provide relief more effectively and quickly. Researchers are excited about this treatment because it might not only protect the skin but also enhance healing by reducing inflammation, offering a dual-action approach that standard care options lack.

What evidence suggests that this treatment might be an effective treatment for diaper rash?

Research has shown that β-glucan cream can effectively soothe diaper rash. In this trial, participants will receive either standard care alone or an adjunctive 0.5% β-glucan cream combined with standard care. Studies have found that products with β-glucan help skin heal faster and reduce irritation. Evidence suggests that adding β-glucan to regular skin care can speed up recovery and ease discomfort such as itching and burning. Known for its gentleness, the cream suits most people. Its calming effects make it a promising choice for treating irritated skin.12367

Who Is on the Research Team?

MD

Marlene Dytoc, MD/PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who have diaper rash or skin irritation caused by urinary and/or fecal incontinence, are expected to stay in the hospital at least 7 days, and can give consent. People with allergies to the cream's ingredients, children, or those without incontinence-related skin issues cannot join.

Inclusion Criteria

I am an adult with skin irritation from urine or stool leakage.
Expected hospital stay of ≥7 days
Written informed consent obtained directly or via substitute decision-maker

Exclusion Criteria

Pediatric patients
Participants with known hypersensitivities to components of cream (e.g. beta-glucan)
Absence of IAD or incontinence

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either β-glucan cream plus standard care or standard care alone. The cream is applied once daily.

2 weeks
Weekly skin checks by the study team

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of IAD severity and patient-reported outcomes.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Soothing Beta Cream (Dr. Mom)

Trial Overview

The study compares a moisturizing beta-glucan cream plus standard care versus standard care alone for treating skin irritation from incontinence. Participants will use the cream daily for up to two weeks while their symptoms and healing progress are monitored.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Standard care aloneExperimental Treatment1 Intervention
Group II: Adjunctive 0.5% β-glucan cream combined with standard careExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

Citations

Soothing Beta Cream for Diaper Rash · Info for Participants

The goal of this clinical trial is to determine whether adding a β-glucan moisturizing cream to routine skin care can enhance skin healing, ...

A Systematic Review and Meta-Analysis

The use of diaper cream or moisturizers, along with soap, was found to be effective in preventing nappy rash. However, only one study reported ...

Improving the Care of Incontinence-Associated Dermatitis ...

The goal of this clinical trial is to determine whether adding a β-glucan moisturizing cream to routine skin care can enhance skin healing, ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41769510/

Clinical Effectiveness of Barrier Preparations in the ...

Additionally, zinc oxide (ZnO) paste showed effectiveness in managing diaper dermatitis among neonates. The use of diaper cream or ...

A new therapeutic horizon in diaper dermatitis: Novel agents ...

The studies confirmed the products' efficacy with very good skin acceptability after application of both products at every diaper change for 28 consecutive days ...

Beta-Glucan: Safe Skincare for Pregnancy Skin Irritation

It excels at soothing irritation and reinforcing the skin barrier, all while boasting an impressive safety profile. Let's explore why beta- ...

Our @bydrmom beta glucan cream is gentle enough for the ...

Our @bydrmom beta glucan cream is gentle enough for the entire family ❤️ and effective for baby and adult skin to manage skin irritation! # ...