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

Sponsor
University of Alberta
Study ID
NCT07524439
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Soothing Beta Cream (Dr. Mom) — DRUG
    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.
  • Standard of Care — OTHER
    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.

Study Details

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

Key Dates

First listed
Apr 13, 2026
Start date
May 1, 2026
Status verified
Jun 2026
Primary completion
May 1, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Standard care alone
  • Experimental: Adjunctive 0.5% β-glucan cream combined with standard care

Primary Outcome Measure

GLOBIAD-M assessment [ Time Frame: Resolution or up to 2 weeks ]

Central Contacts

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