Recruiting

β-Glucan Cream

Sponsor:

University of Alberta

Code:

NCT07524439

Conditions

Fecal Incontinence

Urinary Incontinence

Diaper Rash

Irritant Contact Dermatitis Caused by Faeces

Irritant Contact Dermatitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Soothing Beta Cream (Dr. Mom)

Standard of Care

Study Details

Brief 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

Study ID

NCT07524439

Start date

May 1, 2026

Status verified date

Jun, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Eligible participants are adults (≥18 years) with IAD secondary to urinary and/or fecal incontinence and an expected hospital stay of ≥7 days. Written informed consent will be obtained directly or via substitute decision-maker. Exclusion criteria include absence of IAD or incontinence, pediatric patients, and participants with known hypersensitivities to components of cream (e.g. beta-glucan).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Standard care alone

experimental: Adjunctive 0.5% β-glucan cream combined with standard care

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G2J2

Contacts

More Information

Sponsor

University of Alberta

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Administration, Topical
  • Administration, Cutaneous

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-06-26.