Use of a β-Glucan Cream in Incontinence-Associated Dermatitis

Overview

The goal of this clinical trial is to learn if a topical 0.5% barley-derived β-glucan cream (Soothing Beta Cream, Dr. Mom) works to improve healing of incontinence-associated dermatitis (IAD) in hospitalized adults. 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: Does adding β-glucan cream to standard care reduce the severity of IAD 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

Purpose: The purpose of this study is to evaluate the effectiveness of a topical, non-steroidal 0.5% barley-derived β-glucan cream (Soothing Beta Cream, Dr. Mom) as an adjunct to standard care for incontinence-associated dermatitis (IAD) in adults. Through a randomized controlled trial of this non-invasive intervention, the study will assess whether β-glucan cream enhances skin healing, reduces IAD severity, and alleviates patient-reported symptoms compared with standard care alone, ultimately generating robust evidence to inform and standardize patient care guidelines for the management of this condition. Hypothesis: We hypothesize that adjunctive 0.5% β-glucan cream combined with standard care will result in greater improvement in IAD than standard care alone. Improvement will be evidenced by reductions in GLOBIAD-M scores, shorter time to healing, and improved patient- and clinician-reported symptoms due to the cream's barrier-restorative, anti-inflammatory, and immunomodulatory effects. Justification: Incontinence-associated dermatitis (IAD) is a common and painful inflammatory skin condition resulting from prolonged exposure to urine and/or feces, affecting up to 19% of hospitalized adults in Canada. Structured skincare regimens, including gentle cleansing, moisturization, and barrier products, are widely recognized as essential for the prevention and management of IAD. Despite broad agreement on these core principles, no universally accepted standard of care exists across healthcare settings. A wide variety of cleansers, emollients, and barrier products are used to treat IAD, often selected based on institutional preference, anecdotal experience, or cost considerations rather than robust comparative evidence. This lack of standardized, evidence-based product selection contributes to variability in outcomes, may delay effective skin barrier repair, and can lead to inefficient or suboptimal care practices. β-Glucan, a naturally derived polysaccharide, has well-established barrier-forming, humectant, anti-inflammatory, immunomodulatory, and wound-healing properties. By interacting with the immune receptor dectin-1, β-glucan modulates cytokine production and macrophage activity, mechanisms central to resolving inflammation and promoting tissue regeneration. Additionally, β-glucan exhibits antimicrobial activity, including against Candida species, which may further support healing in skin affected by IAD. Given the variability in care practices and the promising biological properties of β-glucan, a randomized controlled trial (RCT) is warranted to rigorously evaluate the clinical effectiveness of a topical cream created and produced at the University of Alberta, Soothing Beta Cream (Dr. Mom), in the management of IAD. Conducting a well-designed RCT will allow for direct comparison with standard care, providing high-quality evidence on its ability to enhance skin healing, reduce IAD severity, and improve both patient- and clinician-assessed outcomes. Ultimately, this study aims to generate robust, locally relevant data to support standardized treatment guidelines for IAD in Alberta healthcare settings. Objectives: 1. Evaluate the effect of 0.5% β-glucan cream plus standard care versus standard care alone on IAD severity, using the validated GLOBIAD-M tool. 2. Compare time to healing between the intervention and control groups. 3. Assess patient- and clinician-reported outcomes, including pain, itching, tingling, burning, overall symptom improvement, and qualitative feedback on cream acceptability, feel, and ease of application. 4. Evaluate the safety and tolerability of the β-glucan cream in hospitalized adults with IAD, including any adverse effects reported by patients or observed by clinicians. Research Method/Procedures: Study Design This Phase II randomized controlled trial will recruit 60 adults with clinically diagnosed IAD admitted to the inpatient units at the University of Alberta Hospital. Participants will be randomized 1:1 via REDCap to receive either β-glucan cream plus standard care (n = 30) or standard care alone (n = 30). Diagnosis will be confirmed by a geriatrician or dermatologist, with skin biopsy only if clinically indicated. The intervention will be applied once daily, and participants monitored for up to 2 weeks. Inclusion and Exclusion Criteria 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 and pediatric patients. Data Collection and Assessment Procedures Participants will be identified by medical students, residents, physicians, or wound care nurses. Clinical photographs will be taken with secure hospital devices (e.g. Haiku rover) and uploaded to Media Manager on Alberta Health Services (AHS) Connect Care for independent dermatology review. IAD severity will be assessed using GLOBIAD-M at baseline and every week until resolution or a maximum of 2 weeks. Wound assessments include percentage of affected quadrants with redness or skin loss, presence of edema or maceration, and infection signs (0-5). Patient-reported outcomes include itching, tingling, burning, and pain, measured on a 0-10 numeric scale. Qualitive Feedback At the end of the intervention period, brief open-ended survey questions will be administered to both patients and nursing staff. Patients will provide feedback on cream texture, comfort, and any adverse effects. Nursing staff will provide feedback on ease of application, observed reactions, and suggestions for improvement. All qualitative responses will be coded line-by-line and analyzed using thematic analysis, grouping codes into patterns and identifying broader themes. This process will capture patient and clinician perspectives on cream acceptability, usability, tolerability, and overall satisfaction. The findings from thematic analysis will complement quantitative endpoints to provide a comprehensive evaluation of the β-glucan cream's clinical effectiveness and user experience. Feasibility Based on patient volumes, 3-5 eligible participants per week are expected, allowing recruitment within 4-6 months. Plan for Data Analysis: Quantitative Analysis Baseline characteristics of participants (e.g., age, sex, comorbidities, IAD severity at enrollment) will be summarized descriptively, using means and standard deviations for continuous variables and counts and percentages for categorical variables. Primary and secondary outcomes will be analyzed as follows: 1. Continuous outcomes (e.g., percentage of affected skin with redness or skin loss) will be analyzed using linear mixed-effects models, accounting for repeated measures within participants over time. 2. Binary outcomes (e.g., presence of edema, maceration) will be analyzed using generalized linear mixed-effects models with appropriate link functions (e.g., logit). 3. Ordinal outcomes (e.g., GLOBIAD-M severity categories, pain type) will be analyzed using ordinal mixed-effects models, allowing assessment of changes over time between treatment groups. 4. Time-to-event outcomes (e.g., time to full healing) will be analyzed using Kaplan-Meier survival analysis to estimate median healing times and Cox proportional hazards models to compare groups while adjusting for relevant covariates. Assuming a moderate effect size (Cohen's d = 0.7), 26 participants per group provide 80% power at α = 0.05. To allow for attrition, 30 participants per group will be recruited (total n = 60). Adjunctive β-glucan therapy is expected to reduce IAD severity, shorten healing time, and improve patient-reported outcomes compared with standard care alone. Qualitative Analysis: Thematic Analysis Open-ended survey responses from patients and nursing staff will be collected electronically via REDCap on tablets and exported securely for analysis. Responses will be managed using qualitative analysis software (e.g., NVivo) and analyzed using a structured thematic analysis process as follows: 1. Familiarization: Survey responses will be read repeatedly to identify preliminary insights and patterns. 2. Coding: Meaningful units of text (e.g., "smooth texture," "slight burning") will be assigned short descriptive codes that capture key concepts in patient and clinician experiences. 3. Generating Themes: Codes will be grouped into broader themes based on recurring patterns. The following table summarizes anticipated themes, associated codes, and representative example quotes: The participant reported, "The cream felt smooth and soothing, not sticky at all," which was coded as Smooth, soothing, non-sticky, not greasy and grouped under the theme Positive Sensory Experience. The participant reported, "Application was simple and quick," which was coded as Easy to apply, spreads easily, simple and grouped under the theme Ease of Application. The participant reported, "I felt a slight burning the first day," which was coded as Slight burning, tingling, itchiness and grouped under the theme Minor Adverse Effects. The participant reported, "Overall, it seems well-tolerated, and patients seemed comfortable," which was coded as Comfortable, well-tolerated, soothing and grouped under the theme Overall Satisfaction / Tolerability. 4. Reviewing and Refining Themes: Themes will be iteratively reviewed and refined to ensure they accurately represent the experiences reported by patients and nursing staff. 5. Integration with Quantitative Findings: Thematic findings will be summarized descriptively and integrated with quantitative outcomes (e.g., GLOBIAD-M scores, pain, itching, tingling, burning) to provide a comprehensive understanding of clinical effectiveness, safety, usability, and satisfaction.