EpiCeram for Skin Protection in Healthcare Workers (NCT04793711) | Clinical Trial Compass
TerminatedNot Applicable
EpiCeram for Skin Protection in Healthcare Workers
Stopped: Unable to find willing participants.
United States1 participantsStarted 2021-03-15
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. HCW using PPE at least 6 hours/day, 4 days/week or, depending on shift work, 24 hours/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 between screening and baseline visit and for the duration of the study.
. Participant is willing to stop use of or not begin use of any topical corticosteroids, emollients and lotions to the hands and face for the duration of the trial.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial was terminated before completing, does that mean there isn't enough data yet to know whether EpiCream actually helps with symptoms like dryness, cracking, and itching from irritant contact dermatitis, and how does that affect whether it's worth trying?
2Given that this study was specifically focused on healthcare workers using EpiCream for skin protection, does the way I got my irritant contact dermatitis match closely enough that any partial findings from this trial would still be relevant to my situation?
3Since the trial was terminated, are there other completed studies or standard treatments you'd recommend I try first for my symptoms of redness, roughness, and skin cracking before considering anything experimental?
4Because this trial has no listed phase and was stopped early, what does that tell us about how much safety and effectiveness information is actually available for EpiCream as a treatment for my skin condition?
5Are there any other active or completed trials studying barrier creams or emollients for irritant contact dermatitis that might have more reliable data for us to consider together?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Patient Reported Outcome of Overall Skin Irritation Symptoms
. History of any skin disorder existing prior to March 1, 2020 characterized by chronic visible lesions or skin irritation symptoms including, but not limited to atopic 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 the investigator, might put the subject at risk in this trial.
. Participation in another clinical trial within 30 days or 5 half-lives of the study agent, whichever is longer.