Irritant Contact DermatitisNCT04793711
EpiCeram for Skin Protection in Healthcare Workers
A study testing EpiCeram in people with Irritant Contact Dermatitis, run by Primus Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritant Contact Dermatitis
- What is being tested?
- EpiCeram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment
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.
Read the 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.
- Conditions
- Irritant Contact Dermatitis
- Being tested
- EpiCeram
- Keywords
- dermatitis, PPE, healthcare workers
- Medical subject headings
- Dermatitis, Irritant, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiCeramDevice
protective emollient
| Study group | Role | What they receive |
|---|---|---|
| EpiCeram | Experimental | Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days. Receives: Device: EpiCeram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Day 28
Secondary outcomes (3)
Change in Surface Skin pH
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.
Measured: Baseline to Day 28
Change in Transepidermal Water Loss on Skin
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.
Measured: Baseline to Day 28
Change in Stratum Corneum Hydration on Skin
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.
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start15 Mar 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Unable to find willing participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritant Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Primus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Levy, MD, Study director, Director of Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793711
- Sponsor's protocol ID
- PPE-01
- Status last verified
- Jun 2024
- First submitted
- 8 Mar 2021
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EpiCeram for Skin Protection in Healthcare Workers Using Personal Protective Equipment
- ClinicalTrials.gov ID
- NCT04793711
- Acronym / sponsor ID
- PPE-01
- Conditions
- Irritant Contact Dermatitis
- Keywords
- dermatitis, PPE, healthcare workers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to find willing participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Primus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Posted 2 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EpiCeram | Experimental | Device: EpiCeramOpen-Label, 3 (three) times per day, topical, to hands and face, for 28 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpiCeramprotective emollient | Device | EpiCeram |
Primary outcome
Change in Patient Reported Outcome of Overall Skin Irritation Symptoms
Time frame: 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
Time frame: 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
Time frame: 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
Change in Patient Reported Outcome of Dryness
Time frame: 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
Time frame: 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
Time frame: 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 Itching
Time frame: 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
3 secondary outcomes
Change in Surface Skin pH
Time frame: Baseline to Day 28
Change in Transepidermal Water Loss on Skin
Time frame: Baseline to Day 28
Change in Stratum Corneum Hydration on Skin
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Levy, MD study director
Director of Clinical Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EpiCeram in people with Irritant Contact Dermatitis, run by Primus Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Reported Outcome of Overall Skin Irritation Symptoms (time frame: Baseline to Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.