EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment

• ClinicalTrials.gov Identifier: NCT04793711
• Recruitment Status: Terminated
• First Posted: March 11, 2021
• Last Update Posted: July 22, 2021
• Sponsor: Primus Pharmaceuticals
• Information provided by (Responsible Party): Primus Pharmaceuticals

Study Description

Brief Summary:

This is an open-label study using a study device currently being 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 specifically designed to improve skin barrier function in people with diseases known to be associated with barrier defects such as atopic and contact dermatitis. However, EpiCeram has not previously been studied in people with skin irritation due to extensive use of PPE.

Condition or disease	Intervention/treatment	Phase
Irritant Contact Dermatitis	Device: EpiCeram	Not Applicable

Detailed Description:

Description of Procedures At the screening visit, the study will be explained, and the subject will have the opportunity to ask questions. If the subject decides to participate, the subject will have to read, sign and date this Informed Consent Document. The study staff will take the subjects pertinent medical history to evaluate the subjects eligibility for the study. The subject will be asked about the kind of skin products the subject is using as well as about the subjects use of PPE. The subject will rate the subject overall skin irritation on a scale of 0 to 10 with 10 (ten) being worst and 0 (zero) being none. The subject will have to score at least 4 (four) on the overall skin irritation scale to continue in the study.

If the subject had not used any lotions or emollients for the previous one (1) week on the face and hands, Visit 2 activities may be performed at the Screening visit. If the subject had used any lotions or emollients on the face and hands, a washout period will be necessary, and the subject will be asked to refrain from using any lotions and emollients for one (1) week between Visits 1 and 2 and then, for the duration of the study. Visit 2 (Baseline) will occur seven (7) days after Visit 1.

If the subject is accepted into the study, the subject will return to the study site one (1) week later and 28-days later, at which times the subject will complete the same overall irritation scale. The subject will have measurements of skin barrier function tested, specimens of surface cells collected and special photographs taken, all described below.

Photographs: Special 3-D photographs will be taken by a digital camera that records the skin microstructure and wrinkles. This 3D photo will be analyzed and used to assign a number to measure skin roughness and wrinkles and track changes over time. These are not conventional photographs, and the subject cannot be identified. Additional privacy steps will include assigning a number to all documents instead of the subject name.

Skin Function Testing: Measurements of skin water loss and surface skin pH, also known as acidity, will be taken on the skin between the subject knuckles. These measurements are performed by a short, rod-type device, emitting light, placed lightly onto the subject skin. There is no sensation felt and the result is available within seconds.

Laboratory Testing: Two types of specimens will be obtained: a swab and tape stripping. A single skin swab (similar to cotton Q-tips®) will be wiped across the subject palm to collect bacteria. Non-invasive tape stripping of surface cells will be performed at 2 places on the back of the subject hand. This is done by laying a specially made piece of tape, gently on the subject skin and removing it, 3 times, to lift the surface cells. The specimens will be used to estimate the presence, type, and number of specific bacteria.

Finally, the subject will be asked to avoid applying any skin products (except make-up) to the subject skin for the following week and for the duration of the study.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment
• Actual Study Start Date: March 15, 2021
• Actual Primary Completion Date: July 1, 2021
• Actual Study Completion Date: July 1, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: EpiCeram; Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days.	Device: EpiCeram; Barrier cream

Outcome Measures

Primary Outcome Measures :

1. a. Change in patient reported outcome of overall face and hand skin irritation symptoms from baseline to Day 28, of at least 2 points on a 0-10 point scale where 0 = none and 10 = worst. [ Time Frame: From baseline to Day 28 ]
   A subjective assessment by the subject of combined, overall irritation of face and hands using an ordinal scale of 0-10 where 0 = no irritation and 10 = worst irritation felt
2. b. Change in any two of the following specific skin irritation symptoms of at least 2 points on a 0-10 point scale where 0 = none and 10 = worst. 1. pain 2. redness 3. dryness 4. cracking 5. roughness 6. itchiness 7. overall skin irritation [ Time Frame: From baseline to Day 28 ]
   A subjective assessment by the subject of irritation of face and hands for each of 7 symptoms using an ordinal scale of 0-10 where 0 = no irritation and 10 = worst irritation felt

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Arizona

Sun Valley Arthritis Center

Peoria, Arizona, United States, 85381

Sponsors and Collaborators

Primus Pharmaceuticals

Investigators

• Study Director: Robert Levy, MD; Director of Clinical Development

More Information

• Responsible Party: Primus Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT04793711
• Other Study ID Numbers: PPE-01
• First Posted: March 11, 2021
• Last Update Posted: July 22, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Primus Pharmaceuticals:

dermatitis; PPE; healthcare workers

Additional relevant MeSH terms:

Dermatitis; Dermatitis, Contact; Dermatitis, Irritant; Skin Diseases; Skin Diseases, Eczematous; Decanoic acid; Antifungal Agents; Anti-Infective Agents