Clinical trial NCT04793711: EpiCeram for Skin Protection in Healthcare Workers
Official title: EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Irritant Contact Dermatitis
Keywords: dermatitis
PPE
healthcare workers
Lead sponsor: Primus Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Men or women, any age
3. Overall skin irritation score of at least 4 on 0-10 scale where 0 = none and 10 = worst
4. 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.
5. 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:

1. 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.
2. Use of topical corticosteroids within one (1) month of baseline visit.
3. History of any significant medical condition that, in the opinion of the investigator, might put the subject at risk in this trial.
4. Participation in another clinical trial within 30 days or 5 half-lives of the study agent, whichever is longer.

Primary outcomes:
measure: Change in Patient Reported Outcome of Overall Skin Irritation Symptoms
timeFrame: Baseline to Day 28
measure: Change in Patient Reported Outcome of Pain
timeFrame: Baseline to Day 28
measure: Change in Patient Reported Outcome of Redness
timeFrame: Baseline to Day 28
measure: Change in Patient Reported Outcome of Dryness
timeFrame: Baseline to Day 28
measure: Change in Patient Reported Outcome of Cracking
timeFrame: Baseline to Day 28
measure: Change in Patient Reported Outcome of Roughness
timeFrame: Baseline to Day 28
measure: Change in Patient Reported Outcome of Itching
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Change in Surface Skin pH
timeFrame: Baseline to Day 28
measure: Change in Transepidermal Water Loss on Skin
timeFrame: Baseline to Day 28
measure: Change in Stratum Corneum Hydration on Skin
timeFrame: Baseline to Day 28
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Sun Valley Arthritis Center
state: Arizona
Study officials:
affiliation: Director of Clinical Development
name: Robert Levy, MD
role: STUDY_DIRECTOR
References: