Clinical Trial Cream D

Incontinence-associated Dermatitis Clinical Trial

Official title:

Anti-fecal Cream D

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06221046
• Other study ID #: CreamD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: Scotiaderm
• Contact: Ann Gordon, MD
• Phone: 902-698-8372
• Email: dctrakg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the safety and efficacy of a plant extract incorporated into a standard barrier cream in the treatment of rashes from diarrhea or fecal incontinence.

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.

The current standard of care for the treatment and prevention of moisture-associated skin damage involves a structured skin care regiment 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, 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. These rashes can be super-infected by fungal and/or bacterial infection can alter the appearance of the rash and that need to be treated with additional antifungal and or anti-bacterial agents. 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.8 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 is also rich with coliform bacteria, and the gastrointestinal tract acts as a reservoir for various fungal species including Candida that commonly complicates incontinence-associated dermatitis. Liquid stool 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. These effects are exacerbated by a more alkaline pH and the higher concentrations of active fecal enzymes associated with diarrhea. Research on incontinent patients in the ICU shows that the mean time to development of MASD is 4 days. 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.

Research has shown that a family of enzyme inhibitors can been isolated from a subset 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. PBIPs have demonstrated anticarcinogenic activity against tumor cells in vitro, in animal models, and in human phase II clinical trials. In vitro and in vivo studies demonstrate anticarcinogenic activity in a number of animal model systems. PBIP Concentrates (PBIPCs) have the same anticarcinogenic profile as purified PBIPs and have been developed for human trials. 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 PBIPCs 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 purpose of the following proposed research is to explore the safety and efficacy of a plant extract incorporated into a standard barrier in the treatment of MASD from diarrhea or fecal incontinence. The goal of this research is to conduct a randomized double-blind control trial in patients in the ICU with diarrhea or fecal incontinence.

The investigators hypothesizes that Cream D will show improved healing of MASD due to diarrhea or fecal incontinence compared with the standard care (Zinc Oxide) over a seven day period. The primary outcome will be the percentage of patients with improved healing during seven days. Improved healing will be measured by the decrease in two points in the "Severity Scale" of the IAD-ITD Daily Monitoring Tool (a tool developed to track the progress of MASD rashes) and the number of days to healing, the second endpoint will be measured by a decrease in all scales of the IAD-ITD Daily Monitoring Tool during seven days.

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 anticipate that the anti-fecal cream (Cream D) will demonstrate a good safety profile, with no significant adverse events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over the age of 18

• Clinical diagnosis of incontinence-associated dermatitis from fecal incontinence and diarrhea

• A minimum expected length of stay in hospital of seven (7) days or more minimum,

• Able to provide written informed consent (OR consent by a recognized substitute-decision maker) including explicit consent to take daily photographs of the rash associated with MASD

Exclusion Criteria:

• Patients with complex skin disorder

• Allergy to any of the compounds of Cream D

• Length of stay inferior to seven (7) days,

• Life expectancy inferior to seven (7) days

• Visual evidence bacterial infection as defined by the hospital Skin Care Protocol

Related Conditions & MeSH terms

• Dermatitis
• Incontinence-associated Dermatitis
• Intertrigo

Intervention

Other:
• Cream D
Prevention Daily cleansing /moisturizing protection using 3-in-1 perineal wipes after each incontinence episode Avoid rubbing/scrubbing Reduce exposure to moisture as much as possible Reassess frequently Management - no clinical signs of infection MILD/MODERATE Continue with prevention methods, apply CREAM ARM 2 as a barrier product after every fecal incontinence event Discontinue CREAM ARM 2 use after skin has healed If no improvement after 3 days, consult a physician / NP Management - with clinical signs of infection FUNGAL: Continue with prevention methods, adding Clotrimazole 1% cream twice daily. Prescribe order required for Clotrimazole 1% and must be reordered every 7 days unless prescribed for a longer duration Discontinue use after skin has healed If no improvement after 3 days, consult a physician / NP BACTERIAL: requires physician assessment
• Control
Prevention Daily cleansing /moisturizing protection using 3-in-1 perineal wipes after each incontinence episode Avoid rubbing/scrubbing Reduce exposure to moisture as much as possible Reassess frequently Management - no clinical signs of infection MILD/MODERATE Continue with prevention methods, apply CREAM ARM 1 as a barrier product after every fecal incontinence event Discontinue CREAM ARM 1 use after skin has healed If no improvement after 3 days, consult a physician / NP Management - with clinical signs of infection FUNGAL: Continue with prevention methods, adding Clotrimazole 1% cream twice daily. Prescribe order required for Clotrimazole 1% and must be reordered every 7 days unless prescribed for a longer duration Discontinue use after the skin has healed If no improvement after 3 days, consult a physician / NP BACTERIAL: requires physician assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scotiaderm

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and efficacy of the active agent in cream D - Second End-Point	The secondary end-point will be measured by the number of days to achieve a decrease in all scales of the monitoring tool.	7 days
Primary	Safety and efficacy of the active agent in cream D - Dermategrity's fecal cream	The primary outcome measure of this study will be the safety and efficacy of the active agent in cream D (Dermategrity's fecal cream) formulation in the treatment of MASD associated with diarrhea and /fecal incontinence. Safety will be assessed by documenting any adverse events/reactions that occur to patients participating in this study. The efficacy of the barrier cream with a plant-based extract (Cream D) will be compared with the standard of care (Zinc Oxide as per the Valley Regional Hospital Inpatient Skin Care Protocol) by comparing the % patients in each group with complete healing50% healing during the seven days of treatment as measured by the decrease of two points on the "Severity of Erythema" scale, as well as the number of days to achieve healing.	7 days