An interventional study of EpiCeram in Irritant Contact Dermatitis, sponsored by Primus Pharmaceuticals. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-28.
Sponsored by Primus Pharmaceuticals · Not applicable, Interventional, and Treatment
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.
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.
1,425 studies on the registry are indexed under Dermatitis; 127 are open to participants now.
This study's enrollment of 1 is below the median of 64 across 1,124 interventional studies indexed under Dermatitis.
Browse Dermatitis studies →Primus Pharmaceuticals is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days.
Device: EpiCeram
protective emollient
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to Day 28
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Day 28
| Milestone | EpiCeram |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
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
| score on a scale | Active Arm Epiceram |
|---|---|
| Change in Patient Reported Outcome of Overall Skin Irritation Symptoms | 1 (1 to 1) |
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
| score on a scale | Active Arm Epiceram |
|---|---|
| Change in Patient Reported Outcome of Pain | -2 (-2 to -2) |
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
| score on a scale | Active Arm Epiceram |
|---|---|
| Change in Patient Reported Outcome of Redness | 0 (0 to 0) |
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
| score on a scale | Active Arm Epiceram |
|---|---|
| Change in Patient Reported Outcome of Dryness | -1 (-1 to -1) |
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
| score on a scale | Active Arm Epiceram |
|---|---|
| Change in Patient Reported Outcome of Cracking | -1 (-1 to -1) |
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
| score on a scale | Active Arm Epiceram |
|---|---|
| Change in Patient Reported Outcome of Roughness | -1 (-1 to -1) |
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
| score on a scale | Active Arm Epiceram |
|---|---|
| Change in Patient Reported Outcome of Itching | -1 (-1 to -1) |
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.
| unitless | Active Arm Epiceram |
|---|---|
| Change in Surface Skin pH | 0.04 (0.04 to 0.04) |
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.
| grams of water per square meter per hour | Active Arm Epiceram |
|---|---|
| Change in Transepidermal Water Loss on Skin | 14 (14 to 14) |
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.
| arbitrary units | Active Arm Epiceram |
|---|---|
| Change in Stratum Corneum Hydration on Skin | 0 (0 to 0) |
Collected over Screening through Day 28. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Arm EpiCeram | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Active Arm EpiCeram |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Active Arm EpiCeram |
|---|---|
| Female | 1 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active Arm EpiCeram |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 1 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Active Arm EpiCeram |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 1 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Overall Irritation Score(units on a scale) | Active Arm EpiCeram |
|---|---|
| Mean | 7 |
Documents are hosted by the registry — open the source record to download them.
Ran from Mar 2021 to primary completion in Jul 2021, 3 months.
Results were first posted in Nov 2022, 1 year 4 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Primus Pharmaceuticals