Trial Outcomes & Findings for TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (NCT NCT02737748)
NCT ID: NCT02737748
Last Updated: 2023-07-28
Results Overview
The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 7 patients in Phase I
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 0~Day 28
Results posted on
2023-07-28
Participant Flow
This was a multicenter study enrolling subjects from one site in Taiwan and two sites in Japan, between July 06, 2017 and May 07, 2021.
48 subjects were screened in this study; 8 subjects were screen failures, resulting in 40 randomized subjects.
Participant milestones
| Measure |
TWB-103 Group
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. For all assessments, the baseline was defined as the most recently available data before the administration of 1st dose treatment.
|
Placebo Group
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. For all assessments, the baseline was defined as the most recently available data before the administration of 1st dose treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
Phase I
|
3
|
4
|
|
Overall Study
Phase II
|
17
|
16
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds
Baseline characteristics by cohort
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. The baseline was defined as the most recently available data before the administration of 1st dose treatment.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. The baseline was defined as the most recently available data before the administration of 1st dose treatment.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 14.53 • n=5 Participants
|
42.2 years
STANDARD_DEVIATION 14.56 • n=7 Participants
|
43.5 years
STANDARD_DEVIATION 14.41 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Baseline Donor Site Wound (DSW) Size
|
53.37 cm^2
STANDARD_DEVIATION 18.726 • n=5 Participants
|
40.91 cm^2
STANDARD_DEVIATION 19.427 • n=7 Participants
|
47.14 cm^2
STANDARD_DEVIATION 19.863 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0~Day 28Population: Phase I was planned to recruit 3 evaluable subjects each in TWB-103 and Placebo groups. Evaluable subjects in Phase I were (1) he/she who received at least one dose and had follow-up evaluation at least 14 days after the first dose or (2) he/she who received at least one dose and had early withdrawn due to safety reasons before Day 28.
The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 7 patients in Phase I
Outcome measures
| Measure |
TWB-103 Group
n=3 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=4 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)
Treatment-Related AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)
SAEs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 42 or earlierPopulation: Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time \[days\] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time \[days\] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2).
The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=19 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=14 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart Assessed by the Investigator
|
9 Healing Time [days]
Interval 8.0 to 15.0
|
10 Healing Time [days]
Interval 8.0 to 15.0
|
PRIMARY outcome
Timeframe: Days 42 or earlierPopulation: Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time \[days\] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time \[days\] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2).
The number of participants in Phase I and II reached confirmed healing by the investigator within 28 days.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Number of Participants Reached Confirmed Healing Within 28 Days.
|
19 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Days 42 or earlierPopulation: The additional evaluator who was not aware of the treatment groups would assess the wound based on the photos. Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time \[days\] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time \[days\] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2).
The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II. The first additional evaluator judged the healing status by looking at the photos of DSW.
Outcome measures
| Measure |
TWB-103 Group
n=10 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=7 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart, Assessed by the First Additional Evaluator
|
20 Healing Time [days]
Standard Error 2.2
|
13 Healing Time [days]
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Day 7, 10 and 14Population: Healing rates (complete wound closure) of subjects at Days 7, 10, and 14 after DSW creation were analyzed. Due to the study design, subjects would skip the following treatment visits when their wound was completely closed, resulting in the smaller subject numbers at Visit 5 (N=18) and Visit 6 (N=10). To rectify this issue, post-hoc LOCF analysis was performed.
Complete wound closure is defined as skin 100% re-epithelialization without drainage or dressing requirements. This endpoint will be in all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation.
Adjusted Visit 4 (Day 7) with LOCF
|
9 Participants
|
11 Participants
|
|
Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation.
Adjusted Visit 5 (Day 10) with LOCF
|
15 Participants
|
15 Participants
|
|
Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation.
Adjusted Visit 6 (Day 14) with LOCF
|
18 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 7, 10 and 14Population: Healing percentage was measured by the study investigator. Due to the study design, subjects would skip the following treatment visits when their wound was completely closed, resulting in the smaller subject numbers at Visit 5 (N=18) and Visit 6 (N=10). To rectify this issue, post-hoc LOCF analysis was performed.
The healing percentage of wounds will be calculated based on the healing area measured on Day 7, 10 and 14, comparing to the original area measured on Day 0 for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
The Healing Percentage of Wounds (Ratio of Healing Area and Original Area) at Days 7, 10 and 14 After DSW Creation
Adjusted Visit 4 (Day 7) with LOCF
|
65.36 Healing Percentage (%)
Standard Error 8.676
|
62.60 Healing Percentage (%)
Standard Error 8.676
|
|
The Healing Percentage of Wounds (Ratio of Healing Area and Original Area) at Days 7, 10 and 14 After DSW Creation
Adjusted Visit 5 (Day 10) with LOCF
|
89.20 Healing Percentage (%)
Standard Error 5.111
|
83.74 Healing Percentage (%)
Standard Error 5.111
|
|
The Healing Percentage of Wounds (Ratio of Healing Area and Original Area) at Days 7, 10 and 14 After DSW Creation
Adjusted Visit 6 (Day 14) with LOCF
|
88.56 Healing Percentage (%)
Standard Error 5.159
|
83.51 Healing Percentage (%)
Standard Error 5.159
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42, Day 90/180/270/360 from Day 28 or 42Population: The pain assessment was measured by employing short-form McGill pain questionnaire at all scheduled visits, except Visit 2 (Day 0). The visual analogue scale (VAS) for pain is a continuous scale comprised of a horizontal line, usually, 10 cm (= 100 mm) in length, scored from 0 (none) to 10 (extreme). On this scale, a higher score in VAS indicates the worse pain.
All patients in Phase I and II will evaluate the pain based on Short-form McGill pain questionnaire at each visit. The visual analogue scale (VAS) for pain is a continuous scale comprised of a horizontal line, usually, 10 cm (= 100 mm) in length, scored from 0 (none) to 10 (extreme). On this scale, a higher score in VAS indicates the worse pain.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Baseline
|
1.89 VAS (0~10 cm)
Standard Deviation 2.833
|
1.06 VAS (0~10 cm)
Standard Deviation 2.399
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Adjusted Visit 3 (Day 3)
|
1.79 VAS (0~10 cm)
Standard Deviation 2.137
|
1.58 VAS (0~10 cm)
Standard Deviation 2.091
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Adjusted Visit 4 (Day 7)
|
0.82 VAS (0~10 cm)
Standard Deviation 1.313
|
0.40 VAS (0~10 cm)
Standard Deviation 0.701
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Adjusted Visit 5 (Day 10)
|
0.80 VAS (0~10 cm)
Standard Deviation 0.763
|
1.02 VAS (0~10 cm)
Standard Deviation 1.731
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Adjusted Visit 6 (Day 14)
|
0.38 VAS (0~10 cm)
Standard Deviation 0.522
|
1.48 VAS (0~10 cm)
Standard Deviation 2.062
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Adjusted Visit 7 (Day 28)
|
0.37 VAS (0~10 cm)
Standard Deviation 0.713
|
0.35 VAS (0~10 cm)
Standard Deviation 0.943
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Adjusted Visit 8 (Day 42)
|
0.45 VAS (0~10 cm)
Standard Deviation 0.636
|
0.00 VAS (0~10 cm)
Standard Deviation 0.000
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Visit 9 (FU 3 Months)
|
0.40 VAS (0~10 cm)
Standard Deviation 1.588
|
0.06 VAS (0~10 cm)
Standard Deviation 0.236
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Visit 10 (FU 6 Months)
|
0.00 VAS (0~10 cm)
Standard Deviation 0.000
|
0.000 VAS (0~10 cm)
Standard Deviation 0.000
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Visit 11 (FU 9 Months)
|
0.05 VAS (0~10 cm)
Standard Deviation 0.212
|
0.00 VAS (0~10 cm)
Standard Deviation 0.00
|
|
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Visit 12 (FU 12 Months)
|
0.04 VAS (0~10 cm)
Standard Deviation 0.161
|
0.00 VAS (0~10 cm)
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Screening~ Day 360 from Day 28 or 42Population: 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included in the population for safety analysis. Treatment-emergent adverse events (TEAE) were classified as treatment-related AE, Grade 3 or greater AE, AE that required to take special actions, SAE, or SUSAR during the study.
The number of participants with AEs and SAEs will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Number of Participants With AEs and SAEs
AE
|
7 Participants
|
10 Participants
|
|
Number of Participants With AEs and SAEs
Treatment-Related AE
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
Grade≥3 AE
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
Grade ≥ 3 Treatment-Related AE
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
AE Leading to Action Taken
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
AE Leading to Drug withdrawn
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
Death SAE
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
SUSAR
|
0 Participants
|
0 Participants
|
|
Number of Participants With AEs and SAEs
Death SUSAR
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The physical examination of each subject was examined at all scheduled visits.
Changes in post-treatment physical examination will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment Physical Examination Compared to Baseline
Adjusted Visit 3 (Day 3) (Multi-Selection by Body System)
|
1 Participant with Physical Abnormality
|
0 Participant with Physical Abnormality
|
|
Changes in Post-treatment Physical Examination Compared to Baseline
Adjusted Visit 4 (Day 7) (Multi-Selection by Body System)
|
1 Participant with Physical Abnormality
|
0 Participant with Physical Abnormality
|
|
Changes in Post-treatment Physical Examination Compared to Baseline
Adjusted Visit 5 (Day 10) (Multi-Selection by Body System)
|
0 Participant with Physical Abnormality
|
0 Participant with Physical Abnormality
|
|
Changes in Post-treatment Physical Examination Compared to Baseline
Adjusted Visit 6 (Day 14) (Multi-Selection by Body System)
|
0 Participant with Physical Abnormality
|
0 Participant with Physical Abnormality
|
|
Changes in Post-treatment Physical Examination Compared to Baseline
Adjusted Visit 7 (Day 28) (Multi-Selection by Body System)
|
1 Participant with Physical Abnormality
|
0 Participant with Physical Abnormality
|
|
Changes in Post-treatment Physical Examination Compared to Baseline
Visit 8 (Day 42) (Multi-Selection by Body System)
|
0 Participant with Physical Abnormality
|
0 Participant with Physical Abnormality
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The vital signs-pulse rate of each subject was examined at all scheduled visits.
Changes in post-treatment vital signs-pulse rate will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Baseline
|
71.95 Pulse Rate [beats/min]
Standard Deviation 10.359
|
73.90 Pulse Rate [beats/min]
Standard Deviation 15.001
|
|
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Adjusted Visit 3 (Day 3)
|
74.25 Pulse Rate [beats/min]
Standard Deviation 11.964
|
78.20 Pulse Rate [beats/min]
Standard Deviation 13.332
|
|
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Adjusted Visit 4 (Day 7)
|
74.70 Pulse Rate [beats/min]
Standard Deviation 9.314
|
73.55 Pulse Rate [beats/min]
Standard Deviation 11.821
|
|
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Adjusted Visit 5 (Day 10)
|
77.67 Pulse Rate [beats/min]
Standard Deviation 11.554
|
72.33 Pulse Rate [beats/min]
Standard Deviation 8.732
|
|
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Adjusted Visit 6 (Day 14)
|
84.20 Pulse Rate [beats/min]
Standard Deviation 17.021
|
82.40 Pulse Rate [beats/min]
Standard Deviation 7.092
|
|
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Adjusted Visit 7 (Day 28)
|
75.15 Pulse Rate [beats/min]
Standard Deviation 12.119
|
74.79 Pulse Rate [beats/min]
Standard Deviation 12.376
|
|
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Visit 8 (Day 42)
|
71.00 Pulse Rate [beats/min]
Standard Deviation 2.828
|
76.00 Pulse Rate [beats/min]
Standard Deviation 2.828
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The vital signs-body temperature of each subject was examined at all scheduled visits.
Changes in post-treatment vital signs-body temperature will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Baseline
|
36.29 Body Temperature [degree C]
Standard Deviation 0.315
|
36.21 Body Temperature [degree C]
Standard Deviation 0.415
|
|
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Adjusted Visit 3 (Day 3)
|
36.54 Body Temperature [degree C]
Standard Deviation 0.463
|
36.33 Body Temperature [degree C]
Standard Deviation 0.412
|
|
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Adjusted Visit 4 (Day 7)
|
36.47 Body Temperature [degree C]
Standard Deviation 0.455
|
36.52 Body Temperature [degree C]
Standard Deviation 0.465
|
|
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Adjusted Visit 5 (Day 10)
|
36.72 Body Temperature [degree C]
Standard Deviation 0.529
|
36.29 Body Temperature [degree C]
Standard Deviation 0.289
|
|
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Adjusted Visit 6 (Day 14)
|
36.44 Body Temperature [degree C]
Standard Deviation 0.358
|
36.36 Body Temperature [degree C]
Standard Deviation 0.207
|
|
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Adjusted Visit 7 (Day 28)
|
36.35 Body Temperature [degree C]
Standard Deviation 0.363
|
36.33 Body Temperature [degree C]
Standard Deviation 0.333
|
|
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Visit 8 (Day 42)
|
36.30 Body Temperature [degree C]
Standard Deviation 0.141
|
36.35 Body Temperature [degree C]
Standard Deviation 0.212
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The vital signs-systolic blood pressure of each subject was examined at all scheduled visits.
Changes in post-treatment vital signs-systolic blood pressure will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Baseline
|
116.80 Systolic Blood Pressure [mmHg]
Standard Deviation 17.665
|
116.65 Systolic Blood Pressure [mmHg]
Standard Deviation 15.792
|
|
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Adjusted Visit 3 (Day 3)
|
123.45 Systolic Blood Pressure [mmHg]
Standard Deviation 16.794
|
120.30 Systolic Blood Pressure [mmHg]
Standard Deviation 21.293
|
|
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Adjusted Visit 4 (Day 7)
|
118.85 Systolic Blood Pressure [mmHg]
Standard Deviation 12.783
|
121.95 Systolic Blood Pressure [mmHg]
Standard Deviation 15.278
|
|
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Adjusted Visit 5 (Day 10)
|
117.44 Systolic Blood Pressure [mmHg]
Standard Deviation 13.436
|
117.11 Systolic Blood Pressure [mmHg]
Standard Deviation 15.584
|
|
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Adjusted Visit 6 (Day 14)
|
119.80 Systolic Blood Pressure [mmHg]
Standard Deviation 17.584
|
120.00 Systolic Blood Pressure [mmHg]
Standard Deviation 13.304
|
|
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Adjusted Visit 7 (Day 28)
|
124.60 Systolic Blood Pressure [mmHg]
Standard Deviation 10.928
|
121.21 Systolic Blood Pressure [mmHg]
Standard Deviation 11.622
|
|
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Visit 8 (Day 42)
|
140.00 Systolic Blood Pressure [mmHg]
Standard Deviation 12.728
|
122.00 Systolic Blood Pressure [mmHg]
Standard Deviation 5.657
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The vital signs-diastolic blood pressure of each subject was examined at all scheduled visits.
Changes in post-treatment vital signs-diastolic blood pressure will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Baseline
|
71.25 Diastolic Blood Pressure [mmHg]
Standard Deviation 13.325
|
69.90 Diastolic Blood Pressure [mmHg]
Standard Deviation 9.910
|
|
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Adjusted Visit 3 (Day 3)
|
71.50 Diastolic Blood Pressure [mmHg]
Standard Deviation 12.705
|
69.15 Diastolic Blood Pressure [mmHg]
Standard Deviation 10.282
|
|
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Adjusted Visit 4 (Day 7)
|
69.10 Diastolic Blood Pressure [mmHg]
Standard Deviation 6.439
|
76.15 Diastolic Blood Pressure [mmHg]
Standard Deviation 13.374
|
|
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Adjusted Visit 5 (Day 10)
|
68.22 Diastolic Blood Pressure [mmHg]
Standard Deviation 11.745
|
70.00 Diastolic Blood Pressure [mmHg]
Standard Deviation 13.739
|
|
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Adjusted Visit 6 (Day 14)
|
77.60 Diastolic Blood Pressure [mmHg]
Standard Deviation 7.893
|
78.40 Diastolic Blood Pressure [mmHg]
Standard Deviation 11.014
|
|
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Adjusted Visit 7 (Day 28)
|
71.35 Diastolic Blood Pressure [mmHg]
Standard Deviation 11.820
|
77.95 Diastolic Blood Pressure [mmHg]
Standard Deviation 13.323
|
|
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Visit 8 (Day 42)
|
89.50 Diastolic Blood Pressure [mmHg]
Standard Deviation 24.749
|
95.00 Diastolic Blood Pressure [mmHg]
Standard Deviation 2.828
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-hematology-white blood cells of each subject were examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-hematology-white blood cells will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Baseline
|
7.93 10^9 cells /L
Standard Deviation 2.107
|
7.40 10^9 cells /L
Standard Deviation 1.785
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Adjusted Visit 3 (Day 3)
|
7.00 10^9 cells /L
Standard Deviation 1.840
|
7.44 10^9 cells /L
Standard Deviation 2.064
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Adjusted Visit 4 (Day 7)
|
7.20 10^9 cells /L
Standard Deviation 1.638
|
7.26 10^9 cells /L
Standard Deviation 2.835
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Adjusted Visit 5 (Day 10)
|
6.27 10^9 cells /L
Standard Deviation 0.877
|
7.19 10^9 cells /L
Standard Deviation 1.425
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Adjusted Visit 6 (Day 14)
|
9.27 10^9 cells /L
Standard Deviation 4.634
|
7.30 10^9 cells /L
Standard Deviation 0.780
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Adjusted Visit 7 (Day 28)
|
6.52 10^9 cells /L
Standard Deviation 2.110
|
6.99 10^9 cells /L
Standard Deviation 1.760
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Visit 8 (Day 42)
|
4.63 10^9 cells /L
Standard Deviation 1.025
|
6.63 10^9 cells /L
Standard Deviation 1.605
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-hematology-neutrophils of each subject were examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-hematology-neutrophils will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Baseline
|
5.36 10^9 cells /L
Standard Deviation 1.950
|
4.65 10^9 cells /L
Standard Deviation 1.542
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Adjusted Visit 3 (Day 3)
|
4.61 10^9 cells /L
Standard Deviation 1.604
|
4.71 10^9 cells /L
Standard Deviation 1.577
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Adjusted Visit 4 (Day 7)
|
4.54 10^9 cells /L
Standard Deviation 1.431
|
4.37 10^9 cells /L
Standard Deviation 2.322
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Adjusted Visit 5 (Day 10)
|
3.93 10^9 cells /L
Standard Deviation 0.808
|
4.06 10^9 cells /L
Standard Deviation 0.747
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Adjusted Visit 6 (Day 14)
|
6.62 10^9 cells /L
Standard Deviation 4.944
|
4.71 10^9 cells /L
Standard Deviation 0.523
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Adjusted Visit 7 (Day 28)
|
3.94 10^9 cells /L
Standard Deviation 1.733
|
4.19 10^9 cells /L
Standard Deviation 1.128
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Visit 8 (Day 42)
|
2.17 10^9 cells /L
Standard Deviation 0.826
|
3.44 10^9 cells /L
Standard Deviation 0.074
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-hematology-hemoglobin of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-hematology-hemoglobin will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Baseline
|
13.47 Hemoglobin [g/dL]
Standard Deviation 1.436
|
13.84 Hemoglobin [g/dL]
Standard Deviation 1.741
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Adjusted Visit 3 (Day 3)
|
13.28 Hemoglobin [g/dL]
Standard Deviation 1.981
|
13.79 Hemoglobin [g/dL]
Standard Deviation 2.220
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Adjusted Visit 4 (Day 7)
|
13.38 Hemoglobin [g/dL]
Standard Deviation 2.033
|
13.69 Hemoglobin [g/dL]
Standard Deviation 2.002
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Adjusted Visit 5 (Day 10)
|
12.72 Hemoglobin [g/dL]
Standard Deviation 1.796
|
13.56 Hemoglobin [g/dL]
Standard Deviation 1.890
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Adjusted Visit 6 (Day 14)
|
13.22 Hemoglobin [g/dL]
Standard Deviation 2.565
|
13.82 Hemoglobin [g/dL]
Standard Deviation 2.572
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Adjusted Visit 7 (Day 28)
|
13.35 Hemoglobin [g/dL]
Standard Deviation 1.726
|
13.73 Hemoglobin [g/dL]
Standard Deviation 1.665
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Visit 8 (Day 42)
|
14.05 Hemoglobin [g/dL]
Standard Deviation 1.344
|
13.30 Hemoglobin [g/dL]
Standard Deviation 1.697
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-hematology-hematocrit of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-hematology-hematocrit will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Baseline
|
40.60 Hematocrit [%]
Standard Deviation 3.886
|
42.00 Hematocrit [%]
Standard Deviation 4.920
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Adjusted Visit 3 (Day 3)
|
40.01 Hematocrit [%]
Standard Deviation 5.410
|
41.57 Hematocrit [%]
Standard Deviation 6.565
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Adjusted Visit 4 (Day 7)
|
40.35 Hematocrit [%]
Standard Deviation 5.706
|
41.34 Hematocrit [%]
Standard Deviation 5.591
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Adjusted Visit 5 (Day 10)
|
38.07 Hematocrit [%]
Standard Deviation 4.537
|
40.07 Hematocrit [%]
Standard Deviation 5.525
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Adjusted Visit 6 (Day 14)
|
39.84 Hematocrit [%]
Standard Deviation 6.529
|
40.80 Hematocrit [%]
Standard Deviation 7.005
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Adjusted Visit 7 (Day 28)
|
40.43 Hematocrit [%]
Standard Deviation 4.206
|
41.33 Hematocrit [%]
Standard Deviation 4.312
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Visit 8 (Day 42)
|
41.45 Hematocrit [%]
Standard Deviation 1.768
|
42.05 Hematocrit [%]
Standard Deviation 2.192
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-hematology-platelets of each subject were examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-hematology-platelets will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Baseline
|
298.95 10^9 platelets/L
Standard Deviation 69.549
|
284.60 10^9 platelets/L
Standard Deviation 63.444
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Adjusted Visit 3 (Day 3)
|
290.95 10^9 platelets/L
Standard Deviation 63.692
|
278.70 10^9 platelets/L
Standard Deviation 79.961
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Adjusted Visit 4 (Day 7)
|
308.50 10^9 platelets/L
Standard Deviation 50.055
|
279.10 10^9 platelets/L
Standard Deviation 67.043
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Adjusted Visit 5 (Day 10)
|
311.44 10^9 platelets/L
Standard Deviation 67.930
|
247.22 10^9 platelets/L
Standard Deviation 51.575
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Adjusted Visit 6 (Day 14)
|
314.80 10^9 platelets/L
Standard Deviation 81.174
|
225.60 10^9 platelets/L
Standard Deviation 26.885
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Adjusted Visit 7 (Day 28)
|
268.42 10^9 platelets/L
Standard Deviation 68.664
|
260.11 10^9 platelets/L
Standard Deviation 50.326
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Visit 8 (Day 42)
|
248.50 10^9 platelets/L
Standard Deviation 88.388
|
290.50 10^9 platelets/L
Standard Deviation 19.092
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-hematology-red blood cells of each subject were examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-hematology-red blood cells will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Adjusted Visit 4 (Day 7)
|
4.59 10^12 cells/L
Standard Deviation 0.763
|
4.83 10^12 cells/L
Standard Deviation 0.811
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Adjusted Visit 5 (Day 10)
|
4.19 10^12 cells/L
Standard Deviation 0.476
|
4.58 10^12 cells/L
Standard Deviation 0.892
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Baseline
|
4.61 10^12 cells/L
Standard Deviation 0.558
|
4.86 10^12 cells/L
Standard Deviation 0.674
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Adjusted Visit 3 (Day 3)
|
4.54 10^12 cells/L
Standard Deviation 0.729
|
4.82 10^12 cells/L
Standard Deviation 0.824
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Adjusted Visit 6 (Day 14)
|
4.30 10^12 cells/L
Standard Deviation 0.842
|
4.48 10^12 cells/L
Standard Deviation 0.832
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Adjusted Visit 7 (Day 28)
|
4.60 10^12 cells/L
Standard Deviation 0.586
|
4.83 10^12 cells/L
Standard Deviation 0.639
|
|
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Visit 8 (Day 42)
|
4.41 10^12 cells/L
Standard Deviation 0.198
|
5.21 10^12 cells/L
Standard Deviation 0.488
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-aspartate aminotransferase of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-aspartate aminotransferase will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Baseline
|
22.55 Aspartate Aminotransferase [U/L]
Standard Deviation 10.773
|
21.85 Aspartate Aminotransferase [U/L]
Standard Deviation 8.177
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Adjusted Visit 3 (Day 3)
|
33.37 Aspartate Aminotransferase [U/L]
Standard Deviation 46.940
|
20.00 Aspartate Aminotransferase [U/L]
Standard Deviation 5.648
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Adjusted Visit 4 (Day 7)
|
24.75 Aspartate Aminotransferase [U/L]
Standard Deviation 15.210
|
24.40 Aspartate Aminotransferase [U/L]
Standard Deviation 9.762
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Adjusted Visit 5 (Day 10)
|
26.44 Aspartate Aminotransferase [U/L]
Standard Deviation 16.883
|
21.33 Aspartate Aminotransferase [U/L]
Standard Deviation 6.837
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Adjusted Visit 6 (Day 14)
|
45.00 Aspartate Aminotransferase [U/L]
Standard Deviation 43.052
|
22.40 Aspartate Aminotransferase [U/L]
Standard Deviation 12.876
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Adjusted Visit 7 (Day 28)
|
19.05 Aspartate Aminotransferase [U/L]
Standard Deviation 6.060
|
22.00 Aspartate Aminotransferase [U/L]
Standard Deviation 8.931
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Visit 8 (Day 42)
|
32.50 Aspartate Aminotransferase [U/L]
Standard Deviation 23.335
|
19.50 Aspartate Aminotransferase [U/L]
Standard Deviation 3.536
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-alanine aminotransferase of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-alanine aminotransferase will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Adjusted Visit 5 (Day 10)
|
31.89 Alanine Aminotransferase [U/L]
Standard Deviation 29.570
|
26.22 Alanine Aminotransferase [U/L]
Standard Deviation 15.619
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Adjusted Visit 6 (Day 14)
|
62.20 Alanine Aminotransferase [U/L]
Standard Deviation 54.509
|
25.20 Alanine Aminotransferase [U/L]
Standard Deviation 23.868
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Adjusted Visit 7 (Day 28)
|
21.63 Alanine Aminotransferase [U/L]
Standard Deviation 16.780
|
28.28 Alanine Aminotransferase [U/L]
Standard Deviation 24.826
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Visit 8 (Day 42)
|
54.50 Alanine Aminotransferase [U/L]
Standard Deviation 62.933
|
28.00 Alanine Aminotransferase [U/L]
Standard Deviation 2.828
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Baseline
|
25.30 Alanine Aminotransferase [U/L]
Standard Deviation 18.374
|
28.20 Alanine Aminotransferase [U/L]
Standard Deviation 16.776
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Adjusted Visit 3 (Day 3)
|
32.79 Alanine Aminotransferase [U/L]
Standard Deviation 42.926
|
22.95 Alanine Aminotransferase [U/L]
Standard Deviation 14.125
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Adjusted Visit 4 (Day 7)
|
29.25 Alanine Aminotransferase [U/L]
Standard Deviation 24.512
|
27.15 Alanine Aminotransferase [U/L]
Standard Deviation 15.301
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-serum creatinine of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-serum creatinine will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Baseline
|
62.68 Serum Creatinine [umol/L]
Standard Deviation 14.386
|
62.01 Serum Creatinine [umol/L]
Standard Deviation 17.022
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Adjusted Visit 3 (Day 3)
|
58.39 Serum Creatinine [umol/L]
Standard Deviation 14.422
|
61.75 Serum Creatinine [umol/L]
Standard Deviation 18.310
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Adjusted Visit 4 (Day 7)
|
60.51 Serum Creatinine [umol/L]
Standard Deviation 15.129
|
63.78 Serum Creatinine [umol/L]
Standard Deviation 19.811
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Adjusted Visit 5 (Day 10)
|
54.42 Serum Creatinine [umol/L]
Standard Deviation 17.045
|
60.21 Serum Creatinine [umol/L]
Standard Deviation 17.133
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Adjusted Visit 6 (Day 14)
|
57.64 Serum Creatinine [umol/L]
Standard Deviation 19.016
|
63.12 Serum Creatinine [umol/L]
Standard Deviation 37.742
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Adjusted Visit 7 (Day 28)
|
62.44 Serum Creatinine [umol/L]
Standard Deviation 12.363
|
64.63 Serum Creatinine [umol/L]
Standard Deviation 18.637
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Visit 8 (Day 42)
|
56.58 Serum Creatinine [umol/L]
Standard Deviation 5.001
|
66.30 Serum Creatinine [umol/L]
Standard Deviation 6.251
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-blood urea nitrogen of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-blood urea nitrogen will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Baseline
|
13.59 Blood Urea Nitrogen [mg/dL]
Standard Deviation 4.838
|
14.06 Blood Urea Nitrogen [mg/dL]
Standard Deviation 4.271
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Adjusted Visit 3 (Day 3)
|
11.58 Blood Urea Nitrogen [mg/dL]
Standard Deviation 2.234
|
13.23 Blood Urea Nitrogen [mg/dL]
Standard Deviation 3.779
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Adjusted Visit 4 (Day 7)
|
14.46 Blood Urea Nitrogen [mg/dL]
Standard Deviation 3.956
|
14.72 Blood Urea Nitrogen [mg/dL]
Standard Deviation 5.427
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Adjusted Visit 5 (Day 10)
|
13.02 Blood Urea Nitrogen [mg/dL]
Standard Deviation 3.938
|
13.54 Blood Urea Nitrogen [mg/dL]
Standard Deviation 2.967
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Adjusted Visit 6 (Day 14)
|
14.12 Blood Urea Nitrogen [mg/dL]
Standard Deviation 5.304
|
14.48 Blood Urea Nitrogen [mg/dL]
Standard Deviation 3.189
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Adjusted Visit 7 (Day 28)
|
12.82 Blood Urea Nitrogen [mg/dL]
Standard Deviation 3.873
|
13.13 Blood Urea Nitrogen [mg/dL]
Standard Deviation 2.537
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Visit 8 (Day 42)
|
11.90 Blood Urea Nitrogen [mg/dL]
Standard Deviation 2.970
|
16.50 Blood Urea Nitrogen [mg/dL]
Standard Deviation 3.536
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-albumin of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-albumin will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Baseline
|
4.24 Albumin [g/dL]
Standard Deviation 0.411
|
4.08 Albumin [g/dL]
Standard Deviation 0.492
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Adjusted Visit 3 (Day 3)
|
3.99 Albumin [g/dL]
Standard Deviation 0.540
|
3.87 Albumin [g/dL]
Standard Deviation 0.526
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Adjusted Visit 4 (Day 7)
|
4.12 Albumin [g/dL]
Standard Deviation 0.586
|
4.09 Albumin [g/dL]
Standard Deviation 0.528
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Adjusted Visit 5 (Day 10)
|
3.86 Albumin [g/dL]
Standard Deviation 0.529
|
3.98 Albumin [g/dL]
Standard Deviation 0.377
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Adjusted Visit 6 (Day 14)
|
4.02 Albumin [g/dL]
Standard Deviation 0.585
|
4.30 Albumin [g/dL]
Standard Deviation 0.200
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Adjusted Visit 7 (Day 28)
|
4.31 Albumin [g/dL]
Standard Deviation 0.401
|
4.33 Albumin [g/dL]
Standard Deviation 0.387
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Visit 8 (Day 42)
|
4.45 Albumin [g/dL]
Standard Deviation 0.212
|
4.50 Albumin [g/dL]
Standard Deviation 0.283
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-bilirubin of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-bilirubin will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Baseline
|
9.63 Bilirubin [umol/L]
Standard Deviation 4.824
|
8.10 Bilirubin [umol/L]
Standard Deviation 4.975
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Adjusted Visit 3 (Day 3)
|
7.44 Bilirubin [umol/L]
Standard Deviation 3.842
|
8.92 Bilirubin [umol/L]
Standard Deviation 6.039
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Adjusted Visit 4 (Day 7)
|
8.39 Bilirubin [umol/L]
Standard Deviation 5.095
|
8.73 Bilirubin [umol/L]
Standard Deviation 4.876
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Adjusted Visit 5 (Day 10)
|
9.20 Bilirubin [umol/L]
Standard Deviation 5.590
|
9.64 Bilirubin [umol/L]
Standard Deviation 4.470
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Adjusted Visit 6 (Day 14)
|
14.30 Bilirubin [umol/L]
Standard Deviation 10.487
|
9.03 Bilirubin [umol/L]
Standard Deviation 3.058
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Adjusted Visit 7 (Day 28)
|
9.40 Bilirubin [umol/L]
Standard Deviation 6.565
|
9.10 Bilirubin [umol/L]
Standard Deviation 2.873
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Visit 8 (Day 42)
|
18.22 Bilirubin [umol/L]
Standard Deviation 8.829
|
6.84 Bilirubin [umol/L]
Standard Deviation 2.419
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-gamma-glutamyl transferase of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-gamma-glutamyl transferase will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Baseline
|
37.65 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 36.863
|
38.75 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 26.754
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Adjusted Visit 3 (Day 3)
|
37.16 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 31.597
|
37.25 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 26.479
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Adjusted Visit 4 (Day 7)
|
37.60 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 29.674
|
39.65 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 30.275
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Adjusted Visit 5 (Day 10)
|
44.11 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 33.572
|
49.44 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 39.170
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Adjusted Visit 6 (Day 14)
|
56.20 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 36.072
|
47.80 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 43.200
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Adjusted Visit 7 (Day 28)
|
28.47 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 19.234
|
38.22 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 33.676
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Visit 8 (Day 42)
|
32.50 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 24.749
|
21.50 Gamma-Glutamyl Transferase [U/L]
Standard Deviation 0.707
|
SECONDARY outcome
Timeframe: Days 3, 7, 10, 14, 28, 42Population: The general laboratory assessment-biochemistry-alkaline phosphatase of each subject was examined at all scheduled visits.
Changes in post-treatment general laboratory assessment-biochemistry-alkaline phosphatase will be analyzed for all patients in Phase I and II.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Baseline
|
102.65 Alkaline Phosphatase [U/L]
Standard Deviation 74.944
|
107.65 Alkaline Phosphatase [U/L]
Standard Deviation 79.693
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Adjusted Visit 3 (Day 3)
|
97.95 Alkaline Phosphatase [U/L]
Standard Deviation 63.847
|
101.35 Alkaline Phosphatase [U/L]
Standard Deviation 73.382
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Adjusted Visit 4 (Day 7)
|
104.63 Alkaline Phosphatase [U/L]
Standard Deviation 70.811
|
102.85 Alkaline Phosphatase [U/L]
Standard Deviation 71.589
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Adjusted Visit 5 (Day 10)
|
156.22 Alkaline Phosphatase [U/L]
Standard Deviation 74.933
|
158.89 Alkaline Phosphatase [U/L]
Standard Deviation 79.899
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Adjusted Visit 6 (Day 14)
|
138.80 Alkaline Phosphatase [U/L]
Standard Deviation 101.935
|
196.40 Alkaline Phosphatase [U/L]
Standard Deviation 91.694
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Adjusted Visit 7 (Day 28)
|
108.16 Alkaline Phosphatase [U/L]
Standard Deviation 84.534
|
114.00 Alkaline Phosphatase [U/L]
Standard Deviation 82.523
|
|
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Visit 8 (Day 42)
|
156.50 Alkaline Phosphatase [U/L]
Standard Deviation 118.087
|
73.50 Alkaline Phosphatase [U/L]
Standard Deviation 7.778
|
SECONDARY outcome
Timeframe: Screening~ Day 360 from Day 28 or 42The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for all patients in Phase I and II
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)
Treatment-Related AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)
SAEs
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 42 or earlierPopulation: The additional evaluator who was not aware of the treatment groups would assess the wound based on the photos. Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time \[days\] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time \[days\] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2).
The number of censored subjects in Phase I and II assessed by the investigator and the first additional evaluator. The first additional evaluator judged the healing status by looking at the photos of DSW. If the 100% re-epithelialization was not observed by Day 28 visit, the healing time was censored on the day of the last visit up to Day 28 visit. If the 100% re-epithelialization was observed by Day 28 visit but no confirmation was made, the healing time was censored on day of the last visit up to Day 28 visit.
Outcome measures
| Measure |
TWB-103 Group
n=20 Participants
Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
Placebo Group
n=20 Participants
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.
|
|---|---|---|
|
The Number of Censored Subjects Assessed by the Investigator and the First Additional Evaluator
Investigator
|
1 Participants
|
6 Participants
|
|
The Number of Censored Subjects Assessed by the Investigator and the First Additional Evaluator
First Additional Evaluator
|
10 Participants
|
13 Participants
|
Adverse Events
TWB-103 add-on Tegaderm
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo+Tegaderm
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TWB-103 add-on Tegaderm
n=20 participants at risk
TWB-103 is the primary therapeutics with the use of Tegaderm as a wound-site protection
|
Placebo+Tegaderm
n=20 participants at risk
Placebo to TWB-103 with the use of Tegaderm as a wound-site protection
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
General disorders
Application site dermatitis
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
General disorders
Application site discharge
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
10.0%
2/20 • Number of events 2 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
General disorders
Application site erosion
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
General disorders
Application site pruritus
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
15.0%
3/20 • Number of events 3 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
General disorders
Pyrexia
|
10.0%
2/20 • Number of events 3 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Infections and infestations
Application site folliculitis
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Infections and infestations
Skin infection
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Infections and infestations
Wound infection
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/20 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
5.0%
1/20 • Number of events 1 • Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place