Clinical trial NCT06370637: Efficacy of Cream for Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea
Official title: Efficacy of an Enhanced Barrier Cream in the Treatment of Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Incontinence-associated Dermatitis
Moisture Associated Skin Damage (MASD) (E.G., Incontinence-Associated Dermatitis [IAD], Perspiration, Drainage)
Fecal Incontinence Incontinence-associated Dermatitis
Lead sponsor: Scotiaderm
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The aim of this study is to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence.
Primary purpose: TREATMENT

Brief summary: Scotiaderm Inc. has developed a cream formulation to be used in the treatment of MASD caused diarrhea or fecal incontinence. This study aims to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence.

Detailed description: Moisture associated skin damage (MASD) is a grouping of painful, irritating rashes which occur when a patient has repeated or prolonged exposure to moisture from perspiration, urine and/or feces. Commonly encountered rashes in this group include incontinence associated dermatitis (IAD) and intertrigo (ITD). These conditions can affect as many as one in five hospitalized patients and up to 50% of ICU patients, putting them at risk of skin breakdown, serious infection, and the development of pressure ulcers. MASD is a common but overlooked and under-reported skin care problem, and there are many gaps in our knowledge of how best to treat these rashes.

Liquid stool and diarrhea are associated with an increased risk for moisture-associated skin damage (MASD) when fecal materials remain in contact with the skin for a prolonged period. Diarrhea is associated with an increased likelihood of incontinence-associated dermatitis in children and clinical experience strongly suggests that exposure to liquid stool is associated with severe MASD and extensive erosion of affected skin. Liquid stool also contains higher concentrations of proteolytic enzymes with the potential to impair the moisturizing effects of proteins such as filaggrin, and the softening effects of the intrinsic lipids in the skin, both of which are vital in maintaining the barrier functions in skin. The presence of liquid stool is an independent risk factor for the development of IAD, with patients developing IAD 1.5 times more frequently than patients who are continent.

The current standard of care for the treatment and prevention of moisture-associated skin damage involves a structured skin care regimen that involves cleansing of the skin to remove excessive moisture and irritants with a pH balanced cleanser, moisturizing the skin when indicated and applying a protective productive product when repeated exposure to moisture is anticipated. There are many factors that influence the choice of moisturizers and protective products, however a Cochrane review of incontinence-associated dermatitis in 2016 noted that there was no evidence that one product was superior to another. Currently in hospital, a single-step intervention using disposable washcloths that incorporate cleansing, protecting, and skin restoring agents into a single product (3-in-1 wipes) is widely practiced and helps to maximize adherence to best practices in the treatment and prevention of MASD.

Research has shown that a family of enzyme inhibitors can been isolated from a variety of plants. These plant-based inhibitor peptides (PBIPs) have been well characterized and have been shown to reduce the proteolytic activities of enzymes commonly seen in the digestive tract and feces, such as trypsin, chymotrypsin, elastase, cathepsin G, and chymase, serine protease-dependent matrix metalloproteinases, urokinase protein activator, mitogen activated protein kinase, and PI3 kinase, and upregulate connexin 43 (Cx43) expression. Both PBIPs and PBIPCs are nontoxic, and safety has been reported in a phase I trial of PBIPCs administered as an oral troche in patients with oral leukoplakia and treatment for ulcerative colitis. Topical PBIPs have been used safely in clinical studies as hair growth suppressant and treat skin pigmentation.

Scotiaderm Inc. has developed a cream formulation to be used in the treatment of MASD caused diarrhea or fecal incontinence. The aim of this study is to evaluate the efficacy and safety of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea and/or fecal incontinence. The goal of this research is to conduct an open-label outpatient study of this novel cream in a population with MASD secondary to diarrhea and/or fecal incontinence.

The investigators hypothesize that Cream D (15 % Zinc Oxide with 3% plant-based extract) is effective in relieving symptoms of MASD, when self-administered in each bowel movement. In addition, the investigators anticipate that there will be no negative side effects or adverse events due to the use of the cream.

The primary endpoint will be the cumulative symptoms score (pain, burning, itching, bleeding, and discomfort) at 7 days, and a secondary endpoint will be the cumulative symptoms score in 14 days. Symptoms and self-reported healing will be measured by a user journal completed daily for seven days and at day 14. Previous studies of similar topical plant-based extracts can cause reversible mild skin depigmentation and decreased growth and thickness of hair follicles. The plant extract used in Cream D is currently widely found in cosmetic products. The investigators would anticipate that the anti-fecal cream (Cream D) will demonstrate a good safety profile, with no significant adverse events.

Eligibility criteria: Inclusion Criteria:

* Outpatients over the age of 18 years old
* symptomatic incontinence-associated dermatitis from fecal incontinence and/or diarrhea
* able to provide written informed consent
* able to self-administer Cream D

Exclusion Criteria:

* Patients with complex skin disorders,
* Patients with bacterial skin infection,
* Allergy to any of the compounds of Cream D

Primary outcomes:
measure: Analysis of Efficacy and Safety for Cream D Primary Outcome
timeFrame: 14 days
Secondary outcomes:
measure: Analysis of Efficacy and Safety for Cream D Secondary Outcome
timeFrame: 14 days
Other outcomes:
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Study officials:
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