Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT06221046 |
Other study ID # |
CreamD |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.