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EpiCeram for Skin Protection in Healthcare Workers

NCT04793711 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-08-28

Study results available
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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.

Conditions

  • Irritant Contact Dermatitis

Interventions

DEVICE

EpiCeram

protective emollient

Sponsors & Collaborators

  • Primus Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Robert Levy, MD · Director of Clinical Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-15
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04793711 on ClinicalTrials.gov