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 range18 Years – 75 Years

SexALL

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

✕. 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.

What they're measuring

Change in Patient Reported Outcome of Overall Skin Irritation Symptoms

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Pain

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Redness

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Dryness

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Cracking

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Roughness

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Itching

Timeframe: Baseline to Day 28

Trial details

NCT IDNCT04793711

SponsorPrimus Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-01

Results submitted2022-10-06

View on ClinicalTrials.gov More Irritant Contact Dermatitis trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

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

✕. 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.

What they're measuring

Change in Patient Reported Outcome of Overall Skin Irritation Symptoms

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Pain

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Redness

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Dryness

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Cracking

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Roughness

Timeframe: Baseline to Day 28

Change in Patient Reported Outcome of Itching

Timeframe: Baseline to Day 28