Not provided
Not provided
Not provided
Not provided
Not provided
Unable to find willing participants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EpiCeram | Experimental | Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiCeram | Device | protective emollient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 28 |
| Change in Transepidermal Water Loss on Skin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Levy, MD | Director of Clinical Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Valley Arthritis Center | Peoria | Arizona | 85381 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EpiCeram | Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days. EpiCeram: Barrier cream |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Arm EpiCeram | Open-Label to all subjects, no randomization. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Full Range | score on a scale | Baseline to Day 28 |
|
|
Screening through Day 28
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Arm EpiCeram | Open-Label, single-arm, no randomization | 0 |
Not provided
Not provided
Early termination of the study after one subject, limited results and analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Primus Pharmaceuticals, Inc. | 4802506689 | msanstead@primusrx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 | May 30, 2024 | Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D017453 | Dermatitis, Irritant |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
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.
| 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. | Baseline to Day 28 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Overall Irritation Score | Mean | Standard Deviation | units on a scale |
|
|
| Primary | 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 | Posted | Mean | Full Range | score on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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 | Posted | Mean | Full Range | score on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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 | Posted | Mean | Full Range | score on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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 | Posted | Mean | Full Range | score on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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 | Posted | Mean | Full Range | score on a scale | Baseline to Day 28 |
|
|
|
| Primary | 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 | Posted | Mean | Full Range | score on a scale | Baseline to Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | unitless | Baseline to Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | grams of water per square meter per hour | Baseline to Day 28 |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | arbitrary units | Baseline to Day 28 |
|
|
|
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
Not provided
Not provided