Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06370637 |
| Other study ID # |
Survey Protocol |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2024 |
| Est. completion date |
May 2026 |
Study information
| Verified date |
April 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
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.
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.
