NCT04793711

EpiCeram for Skin Protection in Healthcare Workers

EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Primus Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 U.S. 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.

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.

Conditions

• Irritant Contact Dermatitis

Interventions

Type	Name	Description
DEVICE	EpiCeram	protective emollient

Timeline

• Start date: 2021-03-15
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2021-03-11
• Last updated: 2024-08-28
• Results posted: 2022-11-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study