Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04793711
Status:
TERMINATED
Last Update Posted:
2024-06-07
First Post:
2021-03-08
Brief Title:
EpiCeram for Skin Protection in Healthcare Workers
Sponsor:
Primus Pharmaceuticals
Organization:
Primus Pharmaceuticals
Study Overview
Official Title:
EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to find willing participants
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label study using a device currently prescribed by doctors This means everyone involved in the study will know the name of the product only one product will be used and the US Food and Drug Administration FDA has approved the sale of this product Although this is called a device the product is an emollient-type lotion
Healthcare workers HCW often suffer from signs and symptoms of skin irritation including pain redness roughness dryness cracking and itching due to the extensive use of personal protective equipment PPE such as masks and gloves These are thought to be due to changes in the normal skin barrier function induced by repeated minor abrasion in the warm moist environment induced by extensive use of PPE required at work EpiCeram Controlled Skin Barrier Emulsion EpiCeram is a prescription skin barrier repair product containing ingredients designed to improve skin barrier function However EpiCeram has not previously been studied in people with skin irritation due to extensive use of PPE
This study was terminated after 1 one subject was enrolled due to the inability to find willing participants
Healthcare workers HCW often suffer from signs and symptoms of skin irritation including pain redness roughness dryness cracking and itching due to the extensive use of personal protective equipment PPE such as masks and gloves These are thought to be due to changes in the normal skin barrier function induced by repeated minor abrasion in the warm moist environment induced by extensive use of PPE required at work EpiCeram Controlled Skin Barrier Emulsion EpiCeram is a prescription skin barrier repair product containing ingredients designed to improve skin barrier function However EpiCeram has not previously been studied in people with skin irritation due to extensive use of PPE
This study was terminated after 1 one subject was enrolled due to the inability to find willing participants
Detailed Description:
At the screening visit the study will be explained and the participant will have the opportunity to ask questions If the participant decides to enroll they will have to read sign and date this Informed Consent Document The study staff will take the participants pertinent medical history to evaluate eligibility The participant will be asked about the kind of skin products they are using as well as about use of PPE Visit 2 activities may be performed at the Screening visit
Participants will return to the study site one 1 week later and 28-days later to have Photographs Skin Function Testing and Laboratory Testing performed The participant will be asked to avoid applying any skin products except make-up to the skin for the following week and for the duration of the study
Participants will return to the study site one 1 week later and 28-days later to have Photographs Skin Function Testing and Laboratory Testing performed The participant will be asked to avoid applying any skin products except make-up to the skin for the following week and for the duration of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None