Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- GLOBIAD-M assessment
研究概览
简要总结
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
详细描述
Purpose:
The purpose of this study is to evaluate the use of a commercially available cosmetic moisturizer, a topical barley-derived β-glucan cream (Soothing Beta Cream, By Dr. Mom; Cosmetic Notification Number 03481502), as a hydrating and soothing agent when used in addition to standard skin care for adults with incontinence-associated dermatitis (IAD). The study will assess the tolerability, usability, and effects of this cosmetic moisturizer on the visible appearance of moisture-associated skin irritation in hospitalized adults with IAD when used alongside routine cleansing and barrier products.
Hypothesis:
We hypothesize that adding a 0.5% β-glucan moisturizing cream to standard skin care will improve the visible severity of IAD compared with standard care alone. This improvement will be reflected by lower Ghent Global IAD Monitoring Tool (GLOBIAD-M) severity scores, including reductions in redness, skin loss, edema or maceration, and other observable skin changes associated with IAD, as well as shorter time to healing and improvements in patient-reported symptoms such as pain, itching, tingling, and burning captured within the GLOBIAD-M assessment.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •include absence of IAD or incontinence, pediatric patients, and participants with known hypersensitivities to components of cream (e.g. beta-glucan).
研究组 & 干预措施
Standard care alone
干预措施: Standard of Care (Other)
Adjunctive 0.5% β-glucan cream combined with standard care
干预措施: Soothing Beta Cream (Dr. Mom) (Drug)
结局指标
主要结局
GLOBIAD-M assessment
时间窗: 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.
次要结局
- 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)