Trial Outcomes & Findings for EpiCeram for Skin Protection in Healthcare Workers (NCT NCT04793711)
NCT ID: NCT04793711
Last Updated: 2024-08-28
Results Overview
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
TERMINATED
NA
1 participants
Baseline to Day 28
2024-08-28
Participant Flow
Participant milestones
| Measure |
EpiCeram
Open-Label, 3 (three) times per day, topical, to hands and face, for 28 days.
EpiCeram: Barrier cream
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EpiCeram for Skin Protection in Healthcare Workers
Baseline characteristics by cohort
| Measure |
Active Arm EpiCeram
n=1 Participants
Open-Label to all subjects, no randomization.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Overall Irritation Score
|
7 units on a scale
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 28A 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
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Patient Reported Outcome of Overall Skin Irritation Symptoms
|
1 score on a scale
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: Baseline to Day 28A subjective assessment by the subject of pain of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Patient Reported Outcome of Pain
|
-2 score on a scale
Interval -2.0 to -2.0
|
PRIMARY outcome
Timeframe: Baseline to Day 28A subjective assessment by the subject of redness of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Patient Reported Outcome of Redness
|
0 score on a scale
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Baseline to Day 28A subjective assessment by the subject of dryness of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Patient Reported Outcome of Dryness
|
-1 score on a scale
Interval -1.0 to -1.0
|
PRIMARY outcome
Timeframe: Baseline to Day 28A subjective assessment by the subject of cracking of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Patient Reported Outcome of Cracking
|
-1 score on a scale
Interval -1.0 to -1.0
|
PRIMARY outcome
Timeframe: Baseline to Day 28A subjective assessment by the subject of roughness of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Patient Reported Outcome of Roughness
|
-1 score on a scale
Interval -1.0 to -1.0
|
PRIMARY outcome
Timeframe: Baseline to Day 28A subjective assessment by the subject of itching of face and hands using an ordinal scale of 0-10 where 0 = none and 10 = worst
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Patient Reported Outcome of Itching
|
-1 score on a scale
Interval -1.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline to Day 28A portable pH meter together with a combination pH electrode was used to measure pH on skin. An increase in value indicates a better result.
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Surface Skin pH
|
0.04 unitless
Interval 0.04 to 0.04
|
SECONDARY outcome
Timeframe: Baseline to Day 28A 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.
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Transepidermal Water Loss on Skin
|
14 grams of water per square meter per hour
Interval 14.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline to Day 28A 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.
Outcome measures
| Measure |
Active Arm Epiceram
n=1 Participants
Open-Label, single-arm no randomization
|
|---|---|
|
Change in Stratum Corneum Hydration on Skin
|
0 arbitrary units
Interval 0.0 to 0.0
|
Adverse Events
Active Arm EpiCeram
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place