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Irritant Contact Dermatitis

EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment

Sponsored by Primus Pharmaceuticals

About this trial

Last updated 3 years ago

Study ID

PPE-01

Status

Terminated

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status