EpiCeram for Skin Protection in Healthcare Workers

Phase

N/A

Condition

Allergy

Contact Dermatitis (Pediatric)

Eczema (Atopic Dermatitis)

Treatment

EpiCeram

Clinical Study ID

NCT04793711

PPE-01

Ages 18-75
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

HCW using PPE at least 6 hours/day, 4 days/week or, depending on shift work, 24hours/week, for at least one (1) month
Men or women, any age
Overall skin irritation score of at least 4 on 0-10 scale where 0 = none and 10 =worst
Willing to stop use of any other emollient and lotion for one (1) week betweenscreening and baseline visit and for the duration of the study.
Participant is willing to stop use of or not begin use of any topicalcorticosteroids, emollients and lotions to the hands and face for the duration ofthe trial.

Exclusion

Exclusion Criteria:

History of any skin disorder existing prior to March 1, 2020 characterized bychronic visible lesions or skin irritation symptoms including, but not limited toatopic dermatitis, eczema, moderate-severe acne, chronic dry skin and psoriasis.
Use of topical corticosteroids within one (1) month of baseline visit.
History of any significant medical condition that, in the opinion of theinvestigator, might put the subject at risk in this trial.
Participation in another clinical trial within 30 days or 5 half-lives of the studyagent, whichever is longer.

Study Design

EpiCeram

March 15, 2021

July 01, 2021

Study 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.

Connect with a study center

Sun Valley Arthritis Center
Peoria, Arizona 85381
United States
Site Not Available

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