EpiCeram for Skin Protection in Healthcare Workers

EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04793711

Enrollment

Registered

2021-03-11

Start date

2021-03-15

Completion date

2021-07-01

Last updated

2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritant Contact Dermatitis

Keywords

dermatitis, PPE, healthcare workers

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.

Interventions

DEVICEEpiCeram

protective emollient

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Patient Reported Outcome of Itching	Baseline to Day 28	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
Change in Patient Reported Outcome of Dryness	Baseline to Day 28	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
Change in Patient Reported Outcome of Cracking	Baseline to Day 28	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
Change in Patient Reported Outcome of Roughness	Baseline to Day 28	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
Change in Patient Reported Outcome of Overall Skin Irritation Symptoms	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 = none and 10 = worst
Change in Patient Reported Outcome of Pain	Baseline to Day 28	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
Change in Patient Reported Outcome of Redness	Baseline to Day 28	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

Secondary

Measure	Time frame	Description
Change in Transepidermal Water Loss on Skin	Baseline to Day 28	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.
Change in Stratum Corneum Hydration on Skin	Baseline to Day 28	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.
Change in Surface Skin pH	Baseline to Day 28	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Active Arm EpiCeram Open-Label to all subjects, no randomization.	1
Total	1

Baseline characteristics

Characteristic	Active Arm EpiCeram
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Overall Irritation Score	7 units on a scale
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	1 Participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 1
other Total, other adverse events	0 / 1
serious Total, serious adverse events	0 / 1

Outcome results

Primary

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