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Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent

NCT07524439 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-26

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether adding a β-glucan moisturizing cream to routine skin care can enhance skin healing, accelerate visible recovery, reduce discomfort, and improve both patient and clinician experiences. The study will also learn about the safety and tolerability of the β-glucan cream when used along with standard skin care.

The main questions it aims to answer are:

Are there visible changes in the severity of IAD when β-glucan cream is added to standard care, and if so, to what extent does it reduce severity compared with standard care alone?

Does the β-glucan cream help IAD heal faster?

Does the cream reduce symptoms such as pain, itching, tingling, or burning?

What medical problems or side effects, if any, do participants experience while using the β-glucan cream?

Researchers will compare standard care plus β-glucan cream to standard care alone to see if the β-glucan cream provides additional benefit for treating IAD.

Participants will:

Receive either β-glucan cream plus standard care or standard care alone

Have the study cream applied once daily for up to 2 weeks

Have their skin checked weekly by the study team using a standardized assessment tool

Answer questions about symptoms such as pain, itching, tingling, and burning

Allow photographs of the affected skin area to be taken for secure clinical review

Be monitored for any side effects or skin reactions during the study

Conditions

  • Fecal Incontinence
  • Urinary Incontinence
  • Diaper Rash
  • Irritant Contact Dermatitis Caused by Faeces
  • Irritant Contact Dermatitis

Interventions

DRUG

Soothing Beta Cream (Dr. Mom)

Website Description: Soothe and protect sensitive skin with the by Dr Mom Beta-Glucan Cream, a physician-developed, hypoallergenic moisturizer recommended by healthcare professionals for the relief of dry, itchy, irritated skin. Powered by beta-glucan-a naturally derived fiber shown in scientific studies to improve skin hydration and support healing-this gentle cream helps calm inflammation while strengthening the skin barrier.

OTHER

Standard of Care

Current Standard of Care for IAD treatment: Standard of care for IAD management is cleansing followed by application of barrier protection. The cleanser is either with Skintegrity™ Wound Cleanser or normal saline for sensitive skin, and the barrier product is Baza® Protect II Zinc Oxide Skin Protectant Cream (a zinc oxide and dimethicone product) for mild or intact IAD or Coloplast Critic-Aid Clear (a petrolatum and dimethicone product) for moderate to severe IAD.

Sponsors & Collaborators

Principal Investigators

  • Marlene Dytoc, MD/PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-01
Completion
2028-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07524439 on ClinicalTrials.gov