Status:
TERMINATED
EpiCeram for Skin Protection in Healthcare Workers
Lead Sponsor:
Primus Pharmaceuticals
Conditions:
Irritant Contact Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
NA
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. Foo...
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 In...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04793711
Start Date
March 15 2021
End Date
July 1 2021
Last Update
August 28 2024
Active Locations (1)
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1
Sun Valley Arthritis Center
Peoria, Arizona, United States, 85381