Trial Outcomes & Findings for Safety and Tolerability Study of MSC Exosome Ointment (NCT NCT05523011)
NCT ID: NCT05523011
Last Updated: 2024-10-31
Results Overview
All through the treatment period, the subjects completed the Subject Diary to capture the frequency of TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
10 participants
Primary outcome timeframe
Day 1 - 20
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
Exosome Ointment
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Tolerability Study of MSC Exosome Ointment
Baseline characteristics by cohort
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Age, Continuous
|
36.4 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
10 participants
n=5 Participants
|
|
Hematology-Basophils
|
0.036 10^9 Basophils/L
STANDARD_DEVIATION 0.0171 • n=5 Participants
|
|
Hematology-Eosinophils
|
0.144 10^9 Eosinophils/L
STANDARD_DEVIATION 0.1121 • n=5 Participants
|
|
Hematology-Hematocrit
|
41.56 %
STANDARD_DEVIATION 5.214 • n=5 Participants
|
|
Hematology-Hemoglobin
|
13.56 g/dL
STANDARD_DEVIATION 1.896 • n=5 Participants
|
|
Hematology-Lymphocytes
|
1.635 10^9 Lymphocytes/L
STANDARD_DEVIATION 0.3346 • n=5 Participants
|
|
Hematology-Monocytes
|
0.371 10^9 Monocytes/L
STANDARD_DEVIATION 0.1381 • n=5 Participants
|
|
Hematology-Red Blood Cell
|
4.847 10^12 Red blood cells/L
STANDARD_DEVIATION 0.6072 • n=5 Participants
|
|
Hematology-White Blood Cell
|
5.692 10^9 White blood cells/L
STANDARD_DEVIATION 1.7182 • n=5 Participants
|
|
Renal Panel-Bicarbonate
|
26.4 mmol/L
STANDARD_DEVIATION 1.51 • n=5 Participants
|
|
Renal Panel-Blood urea nitrogen
|
10.354 mg/dL
STANDARD_DEVIATION 3.8044 • n=5 Participants
|
|
Renal Panel-Calcium
|
2.290 mmol/L
STANDARD_DEVIATION 0.0887 • n=5 Participants
|
|
Renal Panel-Chloride
|
105.1 mmol/L
STANDARD_DEVIATION 1.66 • n=5 Participants
|
|
Renal Panel-Creatinine
|
65.3 umol/L
STANDARD_DEVIATION 10.92 • n=5 Participants
|
|
Renal Panel-Glucose
|
5.02 mmol/L
STANDARD_DEVIATION 1.094 • n=5 Participants
|
|
Renal Panel-Potassium
|
4.17 mmol/L
STANDARD_DEVIATION 0.445 • n=5 Participants
|
|
Renal Panel-Sodium
|
140.0 mmol/L
STANDARD_DEVIATION 1.56 • n=5 Participants
|
|
Liver Function Test-Alanine transaminase
|
22.1 U/L
STANDARD_DEVIATION 13.56 • n=5 Participants
|
|
Liver Function Test-Albumin
|
43.0 g/L
STANDARD_DEVIATION 2.21 • n=5 Participants
|
|
Liver Function Test-Alkaline phosphatase
|
64.2 U/L
STANDARD_DEVIATION 17.33 • n=5 Participants
|
|
Liver Function Test-Aspartate aminotransferase
|
20.6 U/L
STANDARD_DEVIATION 5.64 • n=5 Participants
|
|
Liver Function Test-Direct bilirubin
|
4.3 umol/L
STANDARD_DEVIATION 2.67 • n=5 Participants
|
|
Liver Function Test-Total bilirubin
|
13.0 umol/L
STANDARD_DEVIATION 9.81 • n=5 Participants
|
|
Inflammatory Blood Examinations-C-reactive protein
|
1.88 mg/L
STANDARD_DEVIATION 2.107 • n=5 Participants
|
|
Inflammatory Blood Examinations-Erythrocyte sedimentation rate
|
13.5 mm/hr
STANDARD_DEVIATION 11.82 • n=5 Participants
|
|
Vital Signs-Systolic Blood Pressure
|
123.5 mmHg
STANDARD_DEVIATION 13.72 • n=5 Participants
|
|
Vital Signs-Diastolic Blood Pressure
|
79.4 mmHg
STANDARD_DEVIATION 13.54 • n=5 Participants
|
|
Vital Signs-Heart Rate
|
78 beats/min
STANDARD_DEVIATION 9.85 • n=5 Participants
|
|
Vital Signs-Respiratory Rate
|
16.2 breaths/min
STANDARD_DEVIATION 2.66 • n=5 Participants
|
|
Vital Signs-Body Temperature
|
36.64 degree Celcius
STANDARD_DEVIATION 0.241 • n=5 Participants
|
|
SCORAD-Dryness
0(None)
|
10 Participants
n=5 Participants
|
|
SCORAD-Dryness
1(Mild)
|
0 Participants
n=5 Participants
|
|
SCORAD-Dryness
2(Moderate)
|
0 Participants
n=5 Participants
|
|
SCORAD-Dryness
3(Severe)
|
0 Participants
n=5 Participants
|
|
SCORAD-Oozing/Crusting
0(None)
|
10 Participants
n=5 Participants
|
|
SCORAD-Oozing/Crusting
1(Mild)
|
0 Participants
n=5 Participants
|
|
SCORAD-Oozing/Crusting
2(Moderate)
|
0 Participants
n=5 Participants
|
|
SCORAD-Oozing/Crusting
3(Severe)
|
0 Participants
n=5 Participants
|
|
SCORAD-Redness
0(None)
|
10 Participants
n=5 Participants
|
|
SCORAD-Redness
1(Mild)
|
0 Participants
n=5 Participants
|
|
SCORAD-Redness
2(Moderate)
|
0 Participants
n=5 Participants
|
|
SCORAD-Redness
3(Severe)
|
0 Participants
n=5 Participants
|
|
SCORAD-Scratch marks
0(None)
|
10 Participants
n=5 Participants
|
|
SCORAD-Scratch marks
1(Mild)
|
0 Participants
n=5 Participants
|
|
SCORAD-Scratch marks
2(Moderate)
|
0 Participants
n=5 Participants
|
|
SCORAD-Scratch marks
3(Severe)
|
0 Participants
n=5 Participants
|
|
SCORAD-Skin thickening
0(None)
|
10 Participants
n=5 Participants
|
|
SCORAD-Skin thickening
1(Mild)
|
0 Participants
n=5 Participants
|
|
SCORAD-Skin thickening
2(Moderate)
|
0 Participants
n=5 Participants
|
|
SCORAD-Skin thickening
3(Severe)
|
0 Participants
n=5 Participants
|
|
SCORAD-Swelling
0(None)
|
10 Participants
n=5 Participants
|
|
SCORAD-Swelling
1(Mild)
|
0 Participants
n=5 Participants
|
|
SCORAD-Swelling
2(Moderate)
|
0 Participants
n=5 Participants
|
|
SCORAD-Swelling
3(Severe)
|
0 Participants
n=5 Participants
|
|
VAS-Itch
|
0.0 units on a scale
STANDARD_DEVIATION 0.00 • n=5 Participants
|
|
VAS-Sleeplessness
|
0.0 units on a scale
STANDARD_DEVIATION 0.00 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 20All through the treatment period, the subjects completed the Subject Diary to capture the frequency of TEAEs.
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Systolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Systolic Blood Pressure After 20 Days of Treatment
|
-4.3 mmHg
Standard Deviation 10.93
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Diastolic blood pressure (mmhg) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Diastolic Blood Pressure After 20 Days of Treatment
|
-9.4 mmHg
Standard Deviation 12.12
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Heart rate (beats/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Heart Rate After 20 Days of Treatment
|
2.3 beats/min
Standard Deviation 10.83
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Respiratory rate (breaths/min) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Respiratory Rate After 20 Days of Treatment
|
0.5 breaths/min
Standard Deviation 3.57
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Body temperature (°C) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Body Temperature After 20 Days of Treatment
|
-0.07 degree Celcius
Standard Deviation 0.263
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Basophils (10\^9 Basophils /L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Basophils After 20 Days of Treatment
|
0.010 10^9 Basophils /L
Standard Deviation 0.0133
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Eosinophils (10\^9 Eosinophils/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Eosinophils After 20 Days of Treatment
|
0.005 10^9 Eosinophils/L
Standard Deviation 0.0276
|
PRIMARY outcome
Timeframe: Day 1 - 21+3hematocrit(%) assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Hematocrit After 20 Days of Treatment
|
0.44 percentage change from baseline
Standard Deviation 0.914
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Hemoglobin (g/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Hemoglobin After 20 Days of Treatment
|
0.13 g/dL
Standard Deviation 0.330
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Lymphocytes (10\^9 Lymphocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Lymphocytes After 20 Days of Treatment
|
0.059 10^9 Lymphocytes/L
Standard Deviation 0.3152
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Monocytes (10\^9 Monocytes/L) were assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Monocytes After 20 Days of Treatment
|
-0.004 10^9 Monocytes/L
Standard Deviation 0.0936
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Red blood cell (10\^12 Red blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Red Blood Cell After 20 Days of Treatment
|
0.034 10^12 Red blood cells/L
Standard Deviation 0.1101
|
PRIMARY outcome
Timeframe: Day 1 - 21+3White Blood Cell (10\^9 White blood cells/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the White Blood Cell After 20 Days of Treatment
|
0.008 10^9 White blood cells/L
Standard Deviation 0.8306
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Bicarbonate (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Bicarbonate After 20 Days of Treatment
|
-1.4 mmol/L
Standard Deviation 2.27
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Blood urea nitrogen (mg/dL) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Blood Urea Nitrogen After 20 Days of Treatment
|
1.800 mg/dL
Standard Deviation 3.1564
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Calcium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Calcium After 20 Days of Treatment
|
0.016 mmol/L
Standard Deviation 0.0538
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Chloride (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Chloride After 20 Days of Treatment
|
0.8 mmol/L
Standard Deviation 1.93
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Creatinine (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Creatinine After 20 Days of Treatment
|
1.3 umol/L
Standard Deviation 5.66
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Glucose (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Glucose After 20 Days of Treatment
|
-0.19 mmol/L
Standard Deviation 1.309
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Potassium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Potassium After 20 Days of Treatment
|
0.17 mmol/L
Standard Deviation 0.263
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Sodium (mmol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Sodium After 20 Days of Treatment
|
0.4 mmol/L
Standard Deviation 1.78
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Alanine transaminase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Alanine Transaminase After 20 Days of Treatment
|
0.6 U/L
Standard Deviation 8.85
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Albumin (g/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Albumin After 20 Days of Treatment
|
0.4 g/L
Standard Deviation 1.90
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Alkaline phosphatase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Alkaline Phosphatase After 20 Days of Treatment
|
2.9 U/L
Standard Deviation 3.11
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Aspartate aminotransferase (U/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Aspartate Aminotransferase After 20 Days of Treatment
|
1.3 U/L
Standard Deviation 5.48
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Direct bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Direct Bilirubin After 20 Days of Treatment
|
1.0 umol/L
Standard Deviation 1.41
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Total bilirubin (umol/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Total Bilirubin After 20 Days of Treatment
|
1.0 umol/L
Standard Deviation 4.27
|
PRIMARY outcome
Timeframe: Day 1 - 21+3C-reactive protein (mg/L) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the C-reactive Protein After 20 Days of Treatment
|
-0.11 mg/L
Standard Deviation 0.409
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Erythrocyte sedimentation rate (mm/hr) was assessed on Day 1 (pre-treatment) and Day 21 (+3 days)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Change From Baseline in the Erythrocyte Sedimentation Rate After 20 Days of Treatment
|
-2.0 mm/hr
Standard Deviation 4.90
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Visual assessments of the dryness of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Dryness of the Area of Application
Day 1 · 0(None)
|
10 Participants
|
|
Assessment of the Dryness of the Area of Application
Day 1 · 1(Mild)
|
0 Participants
|
|
Assessment of the Dryness of the Area of Application
Day 1 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Dryness of the Area of Application
Day 1 · 3(Severe)
|
0 Participants
|
|
Assessment of the Dryness of the Area of Application
Day 21+3 · 0(None)
|
10 Participants
|
|
Assessment of the Dryness of the Area of Application
Day 21+3 · 1(Mild)
|
0 Participants
|
|
Assessment of the Dryness of the Area of Application
Day 21+3 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Dryness of the Area of Application
Day 21+3 · 3(Severe)
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Visual assessments of the oozing/crusting of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 1 · 0(None)
|
10 Participants
|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 21+3 · 0(None)
|
10 Participants
|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 1 · 1(Mild)
|
0 Participants
|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 1 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 1 · 3(Severe)
|
0 Participants
|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 21+3 · 1(Mild)
|
0 Participants
|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 21+3 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Oozing/Crusting of the Area of Application
Day 21+3 · 3(Severe)
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Visual assessments of the rednessof the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Redness of the Area of Application
Day 1 · 0(None)
|
10 Participants
|
|
Assessment of the Redness of the Area of Application
Day 1 · 1(Mild)
|
0 Participants
|
|
Assessment of the Redness of the Area of Application
Day 1 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Redness of the Area of Application
Day 1 · 3(Severe)
|
0 Participants
|
|
Assessment of the Redness of the Area of Application
Day 21+3 · 0(None)
|
10 Participants
|
|
Assessment of the Redness of the Area of Application
Day 21+3 · 1(Mild)
|
0 Participants
|
|
Assessment of the Redness of the Area of Application
Day 21+3 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Redness of the Area of Application
Day 21+3 · 3(Severe)
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Visual assessments of the scratch marks the area of application were carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Scratch Marks of the Area of Application
Day 21+3 · 1(Mild)
|
0 Participants
|
|
Assessment of the Scratch Marks of the Area of Application
Day 21+3 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Scratch Marks of the Area of Application
Day 21+3 · 3(Severe)
|
0 Participants
|
|
Assessment of the Scratch Marks of the Area of Application
Day 1 · 0(None)
|
10 Participants
|
|
Assessment of the Scratch Marks of the Area of Application
Day 1 · 1(Mild)
|
0 Participants
|
|
Assessment of the Scratch Marks of the Area of Application
Day 1 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Scratch Marks of the Area of Application
Day 1 · 3(Severe)
|
0 Participants
|
|
Assessment of the Scratch Marks of the Area of Application
Day 21+3 · 0(None)
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Visual assessments of the skin thickening the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days). SCORAD scale assessment (range: 0-3) 0= none, 1= mild, 2= moderate, 3= severe
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Skin Thickening of the Area of Application
Day 1 · 0(None)
|
10 Participants
|
|
Assessment of the Skin Thickening of the Area of Application
Day 21+3 · 1(Mild)
|
0 Participants
|
|
Assessment of the Skin Thickening of the Area of Application
Day 21+3 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Skin Thickening of the Area of Application
Day 21+3 · 3(Severe)
|
0 Participants
|
|
Assessment of the Skin Thickening of the Area of Application
Day 1 · 1(Mild)
|
0 Participants
|
|
Assessment of the Skin Thickening of the Area of Application
Day 1 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Skin Thickening of the Area of Application
Day 1 · 3(Severe)
|
0 Participants
|
|
Assessment of the Skin Thickening of the Area of Application
Day 21+3 · 0(None)
|
10 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Visual assessments of the swelling of the area of application was carried out using an adapted version of SCORAD scale on Day 1 (pre-treatment) and Day 21 (+3 days).
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Swelling of the Area of Application
Day 21+3 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Swelling of the Area of Application
Day 21+3 · 3(Severe)
|
0 Participants
|
|
Assessment of the Swelling of the Area of Application
Day 1 · 0(None)
|
10 Participants
|
|
Assessment of the Swelling of the Area of Application
Day 1 · 1(Mild)
|
0 Participants
|
|
Assessment of the Swelling of the Area of Application
Day 1 · 2(Moderate)
|
0 Participants
|
|
Assessment of the Swelling of the Area of Application
Day 1 · 3(Severe)
|
0 Participants
|
|
Assessment of the Swelling of the Area of Application
Day 21+3 · 0(None)
|
10 Participants
|
|
Assessment of the Swelling of the Area of Application
Day 21+3 · 1(Mild)
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Subjective symptoms: The identified area of application was assessed for the subjective symptom itch, graded from 0 (no itch) to 10 (worst imaginable itch)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Itch of the Area of Application
Day 1
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Assessment of the Itch of the Area of Application
Day 21+3
|
0.0 score on a scale
Standard Deviation 0.00
|
PRIMARY outcome
Timeframe: Day 1 - 21+3Subjective symptoms: The participant was assessed for the subjective symptom sleeplessness and graded from 0 (no sleeplessness) to 10 (worst imaginable sleeplessness)
Outcome measures
| Measure |
Exosome Ointment
n=10 Participants
The subjects will apply exosome ointment along with Vesiderm liposome cream (TID per day, 20 days). Each day (from Day 1 to 20), the study product will be applied with a gap of 4 hours between three doses to a healthy area (one hand area) on the forearm using 1 fingertip unit (FTU). The Vesiderm liposome cream is meant to keep the application site moisturized.
Exosome ointment: 100 µg MSC exosomes/g ointment
|
|---|---|
|
Assessment of the Sleeplessness
Day 1
|
0.0 score on a scale
Standard Deviation 0.00
|
|
Assessment of the Sleeplessness
Day 21+3
|
0.0 score on a scale
Standard Deviation 0.00
|
Adverse Events
Exosome Ointment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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