EpiCeram for Skin Protection in Healthcare Workers

EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment

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.

Study Overview

• Status: Terminated
• Conditions: Irritant Contact Dermatitis
• Intervention / Treatment: Device: EpiCeram

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Sun Valley Arthritis Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EpiCeram; Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days.	Device: EpiCeram; protective emollient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Reported Outcome of Overall Skin Irritation Symptoms	A subjective assessment by the subject of combined, overall irritation of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst	Baseline to Day 28
Change in Patient Reported Outcome of Pain	A subjective assessment by the subject of pain of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst	Baseline to Day 28
Change in Patient Reported Outcome of Redness	A subjective assessment by the subject of redness of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst	Baseline to Day 28
Change in Patient Reported Outcome of Dryness	A subjective assessment by the subject of dryness of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst	Baseline to Day 28
Change in Patient Reported Outcome of Cracking	A subjective assessment by the subject of cracking of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst	Baseline to Day 28
Change in Patient Reported Outcome of Roughness	A subjective assessment by the subject of roughness of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst	Baseline to Day 28
Change in Patient Reported Outcome of Itching	A subjective assessment by the subject of itching of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst	Baseline to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Surface Skin pH	A portable pH meter together with a combination pH electrode was used to measure pH on skin. An increase in value indicates a better result.	Baseline to Day 28
Change in Transepidermal Water Loss on Skin	A light source wand was used to measure the outcome on skin of the dominant hand. Values were measured from 0 to 80 grams of water per square meter per hour; where 0 is equal to a very low level of water loss and 80 is the highest amount of water loss measured. An decrease in value indicates improvement.	Baseline to Day 28
Change in Stratum Corneum Hydration on Skin	A light source wand was used to measure the outcome on skin of the dominant hand. Values were measured from 0 to 80; where 0 is equal to a very low level of hydration and 80 is the highest amount of hydration measured. An increase in value indicates improvement.	Baseline to Day 28

Collaborators and Investigators

• Sponsor: Primus Pharmaceuticals
• Investigators: Study Director: Robert Levy, MD, Director of Clinical Development

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: dermatitis; PPE; healthcare workers
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Contact; Dermatitis, Irritant; Anti-Infective Agents; Antifungal Agents; Decanoic acid
• Other Study ID Numbers: PPE-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes