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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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

Eligibility

Primary outcome measure(s)

• GLOBIAD-M assessment — Resolution or up to 2 weeks
  IAD categorization: 1A: Persistent redness without clinical signs of infection 1. B: Persistent redness with clinical signs of infection 2. A: Skin Loss without clinical signs of infection 2B: Skin Loss with clinical signs of infection Persistent redness is quantified by number of quadrant squares affected (0-100%). Skin loss is quantified by number of quadrant squares affected (0-100%). Clinical signs of infection is quantified by how many signs are present (0-5 signs) with the signs being the following: Satellite lesions (pustules surrounding the lesion, suggesting a Candida albicans fungal infection), White scaling of the surrounding skin (suggesting a fungal infection), changes in color in the wound bed (such as green, yellow, brown, greyish), purulent exudate (pus), excessive exudate levels.

Trial sites (1)

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