EpiCeram for Skin Protection in Healthcare Workers

NCT04793711 | Terminated Results FDA Device

• 1 other identifier: PPE-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritant Contact Dermatitis

Keywords

dermatitis; PPE; healthcare workers

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Change in Surface Skin pH

  Baseline to Day 28

• Change in Transepidermal Water Loss on Skin

  Baseline to Day 28

• Change in Stratum Corneum Hydration on Skin

  Baseline to Day 28

Study Arms (1)

EpiCeram

EXPERIMENTAL

Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days.

Device: EpiCeram

Interventions

EpiCeram DEVICE

protective emollient

EpiCeram

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Participation in another clinical trial within 30 days or 5 half-lives of the study agent, whichever is longer.

Sponsors & Collaborators

• Primus Pharmaceuticals: lead

Study Sites (1)

Sun Valley Arthritis Center

Peoria, Arizona, 85381, United States

Location

MeSH Terms

Conditions

Dermatitis, Irritant; Dermatitis

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Limitations and Caveats

Early termination of the study after one subject, limited results and analysis.

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Primus Pharmaceuticals, Inc.

msanstead@primusrx.com

4802506689

Study Officials

• Robert Levy, MD

  Director of Clinical Development

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 11, 2021
• Study Start: March 15, 2021
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 28, 2024
• Results First Posted: November 2, 2022

Record last verified: 2024-06

Locations

US (1)