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

NCT07524439 | Not Yet Recruiting

• 1 other identifier: Pro00162249
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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; Irritant Contact Dermatitis Caused by Faeces

Keywords

Administration, Topical; Administration, Cutaneous

Outcome Measures

Primary Outcomes (1)

• GLOBIAD-M assessment

  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.

  Resolution or up to 2 weeks

Secondary Outcomes (4)

• Time to healing

  Resolution or up to 2 weeks

• Patient- and clinician-reported outcomes

  Resolution or up to 2 weeks

• Safety and tolerability

  Resolution or up to 2 weeks

• Additional GLOBIAD-M assessment

  Resolution or up to 2 weeks

Study Arms (2)

Standard care alone

OTHER

Other: Standard of Care

Adjunctive 0.5% β-glucan cream combined with standard care

EXPERIMENTAL

Drug: Soothing Beta Cream (Dr. Mom)

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.

Adjunctive 0.5% β-glucan cream combined with standard care

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.

Standard care alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G2J2, Canada

Location

MeSH Terms

Conditions

Fecal Incontinence; Urinary Incontinence; Diaper Rash; Dermatitis, Irritant

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Marlene Dytoc, MD/PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eileen Tang, BSc

CONTACT

7802636245; eatang@ualberta.ca

Marlene Dytoc, MD/PhD

CONTACT

7802319335; mdytoc@mdskinhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Because this is a parallel-group study with blinded outcome assessment rather than a double-blind design, routine unblinding is not applicable. Participants and treating staff are aware of treatment allocation, while outcome assessors remain blinded. Topical β-glucan is associated primarily with mild, localized skin reactions such as redness, irritation, or itching, and true systemic allergic reactions (e.g., anaphylaxis) are extremely rare. In the unlikely event of a suspected adverse skin reaction potentially related to the β-glucan cream, the study intervention will be discontinued and the participant will receive standard clinical care as indicated. Knowledge of treatment allocation will not need to be disclosed to outcome assessors in order to manage adverse events. Outcome assessors will remain blinded to treatment allocation at all times. Any adverse events and any actions taken in response will be documented and reviewed as part of ongoing safety monitoring.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)