Testing the Safety and Efficacy of a Novel Barrier Cream for the Treatment of Moisture Associated Skin Damage

Launched by SCOTIADERM · Jan 14, 2024

Keywords

ClinConnect Summary

This clinical trial, called Cream D, is looking at a new treatment for skin rashes caused by conditions like diarrhea or fecal incontinence, which can lead to irritation and discomfort. The trial is testing a barrier cream that includes a plant extract to see if it is safe and effective in helping these skin issues. It is important to note that the trial is not yet recruiting participants.

To be eligible for this trial, participants need to be over 18 years old and have a clinical diagnosis of a specific type of skin rash caused by fecal incontinence or diarrhea. They should also expect to stay in the hospital for at least seven days. Participants will provide consent to take daily photographs of their rash to help track its progress. However, individuals with certain complex skin disorders, allergies to any ingredients in the cream, or those who may not be in the hospital for long enough will not be able to join the study. Overall, this trial aims to find better ways to care for patients suffering from these challenging skin conditions.

Gender

ALL

Eligibility criteria

• Patients who meet all the below criteria will be eligible for inclusion in the study:
• • ≥18 years of age;
• • Clinical diagnosis of incontinence-associated dermatitis resulting from diarrhea and/or fecal incontinence;
• • Minimum expected stay in hospital of two weeks;
• • 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.
• Patients who meet any of the following exclusion criteria will not be eligible for enrolment:
• • History of complex skin disorders (such as psoriasis or eczema);
• • Allergy to any of the ingredients in the study product;
• • Visual evidence of a bacterial skin infection;
• • Anticipated length of stay in hospital less than two weeks;
• • Life expectancy less than two weeks;
• • Use of a dressing or bandage covering the rash that cannot reasonably be removed for required study activities without compromising patient comfort or care.
• • Note: Patients who are pregnant will not be excluded from the study unless they present with a rash or other skin conditions that may confound assessments.