protocolSection identificationModule nctId: NCT06370637, orgStudyIdInfo id: Survey Protocol, briefTitle: Efficacy of Cream for Moisture Associated Skin Damage From Fecal Incontinence and/or Diarrhea, acronym: Survey, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-17, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Scotiaderm, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Incontinence-associated Dermatitis, conditions: Moisture Associated Skin Damage (MASD) (E.G., Incontinence-Associated Dermatitis [IAD], Perspiration, Drainage), conditions: Fecal Incontinence Incontinence-associated Dermatitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: A total of 40 patients will be enrolled in the study. If the patient agrees to participate and written consent is given to participate, the research coordinator will assess the eligibility criteria of the patient based on the inclusion and exclusion criteria. Participants will be provided 2x2cm patch test on the forearm to test for contact dermatitis to the cream D after obtaining consent. Participants do not react to the Cream D will be randomized. Participants who react will be excluded from the study. The research coordinator will have a list for arm 1 and arm 2 where the code for the participant enrolled will be entered daily. The first participants to be enrolled on any given day will be assigned to arm 1, and the second patient to arm 2. The research coordinator will have 40 envelopes with the protocols coded with arm 1 or arm 2, and cream containers also coded with arm 1 and arm 2., whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: MASD Control Arm, outcomesModule primaryOutcomes measure: Analysis of Efficacy and Safety for Cream D Primary Outcome, secondaryOutcomes measure: Analysis of Efficacy and Safety for Cream D Secondary Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False