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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.


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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT02991833 - Developing Of A New Incontinence Care Product Early Phase 1
Terminated NCT03298113 - Comparative Study to Assess an Advanced Skin Protectant in the Management of Incontinence-associated Dermatitis N/A
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Terminated NCT02475512 - Comparison of Wash Wipes and Standard Care in the Prevention of Incontinence-associated Dermatitis in Elderly N/A
Completed NCT02690753 - Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning N/A
Recruiting NCT05403762 - Prevention of Incontinence-associated Dermatitis N/A
Terminated NCT04625426 - Evaluation of Skin Cleansers and Skin Protectants in Management of Incontinence-associated Dermatitis N/A
Withdrawn NCT05275257 - Can the Use of Uricap Female Device Lead to Better Care for Women > 75+Years? N/A
Not yet recruiting NCT06363786 - Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters N/A