Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF (NCT NCT02991040)
NCT ID: NCT02991040
Last Updated: 2019-04-11
Results Overview
Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
at injection Time 0
Results posted on
2019-04-11
Participant Flow
The study was undertaken between August 24 2016 and June 21 2017. Subjects that were randomized, there were 100 intent-to-treat (ITT), 95 modified intent-to-treat (mITT), 75 per-protocol (PP) subjects. Of the subjects randomized there were 17 subjects in the rollover subset (17 ITT, 12 mITT, and 12 PP subjects). 96 Subjects completed the study.
Participant milestones
| Measure |
Revanesse Ultra+
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
96
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Revanesse Ultra+
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
Study to Evaluate Safety and Efficacy of Revanesse® Ultra + vs Revanesse® Ultra for Correction of NLF
Baseline characteristics by cohort
| Measure |
Revanesse Ultra+
n=100 Participants
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
|---|---|
|
Age, Categorical
<=18 years
|
NA Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
58.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 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
United States
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at injection Time 0Population: mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face
Visual Analog Scale for Pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher scores mean a worse outcome
Outcome measures
| Measure |
Revanesse Ultra+
n=95 Participants
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
n=95 Participants
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
Pain at Injection as Measured by Subject on a 100 mm Visual Analog Scale (VAS) Scale at Time 0 Minutes Post Injection
|
26.2 VAS
Standard Deviation 24.51
|
39.4 VAS
Standard Deviation 25.45
|
SECONDARY outcome
Timeframe: 15, 30, 45, and 60 minutes post injection and at 2 weeks post injectionPopulation: mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face
Visual Analog Scale for pain. A 100 mm scale with 0 mm being no pain (best outcome) to 100 mm being worst pain (worst outcome). The higher score means a worse outcome.
Outcome measures
| Measure |
Revanesse Ultra+
n=95 Participants
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
n=95 Participants
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
15 minutes post injection
|
9.52 VAS score
Standard Deviation 14.83
|
15.26 VAS score
Standard Deviation 18.37
|
|
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
30 minutes post injection
|
4.72 VAS score
Standard Deviation 9.10
|
7.46 VAS score
Standard Deviation 11.06
|
|
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
45 minutes post injection
|
2.66 VAS score
Standard Deviation 6.61
|
4.21 VAS score
Standard Deviation 7.89
|
|
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
60 minutes post injection
|
2.13 VAS score
Standard Deviation 6.39
|
2.86 VAS score
Standard Deviation 7.28
|
|
Pain Measured by Subject on 100 mm VAS Scale at 15, 30, 45, and 60 Minutes Post Injection and at 2 Weeks Post Injection
2 weeks post injection
|
0.25 VAS score
Standard Deviation 1.07
|
0.25 VAS score
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)Population: mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.
The Wrinkle Severity Rating Scale is a 5-point scale with 1 = Absent; 2 = Mild; 3 = Moderate; 4 = Severe and 5 = Extreme. 1 is the best outcome while 5 is the worst outcome. The higher scores mean a worse outcome.
Outcome measures
| Measure |
Revanesse Ultra+
n=95 Participants
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
Wrinkle Severity Rating Score (WSRS)
Visit 2/Week 2
|
-0.03 Wrinkle Severity Rating scale
Standard Deviation 0.402
|
—
|
|
Wrinkle Severity Rating Score (WSRS)
Visit 3/ Week 4
|
0.02 Wrinkle Severity Rating scale
Standard Deviation 0.25
|
—
|
|
Wrinkle Severity Rating Score (WSRS)
Visit 4/Week 12
|
0.00 Wrinkle Severity Rating scale
Standard Deviation 0.21
|
—
|
|
Wrinkle Severity Rating Score (WSRS)
Visit 5/Week 24
|
-0.02 Wrinkle Severity Rating scale
Standard Deviation 0.25
|
—
|
SECONDARY outcome
Timeframe: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)Population: mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face.
Patient Global Aesthetic Improvement Score is a 5-point scale used to assess the subject's satisfaction with the visual appearance of their NLF correction after treatment. 1 = Worse (worst outcome), 2 = No Change, 3 = Improved, 4 = Much Improved, 5 = Very Much improved (best outcome). The higher scores mean a better outcome.
Outcome measures
| Measure |
Revanesse Ultra+
n=93 Participants
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
Patient Global Aesthetic Improvement
Visit 2/Week 2
|
0.04 score on a scale
Standard Deviation .35
|
—
|
|
Patient Global Aesthetic Improvement
Visit 3/Week 4
|
-0.10 score on a scale
Standard Deviation 0.42
|
—
|
|
Patient Global Aesthetic Improvement
Visit 4/Week 12
|
-0.07 score on a scale
Standard Deviation 0.38
|
—
|
|
Patient Global Aesthetic Improvement
Visit 5/Week 24
|
0.00 score on a scale
Standard Deviation 0.46
|
—
|
SECONDARY outcome
Timeframe: Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)Population: mITT: All randomized subjects who met the inclusion/exclusion criteria, were randomized, received both study products, and had VAS pain score immediately post injection from both sides of the face
Investigator Global Aesthetic Improvement Score is a 5-point scale with 1 = Worse (worst outcome); 2 = No Change; 3 = Improved; 4 = Much Improved, 5 = Very much improved (best outcome). The higher scores mean a better outcome.
Outcome measures
| Measure |
Revanesse Ultra+
n=93 Participants
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
Investigator Global Aesthetic Improvement
Visit 2/Week 2
|
0.02 score on a scale
Standard Deviation 0.48
|
—
|
|
Investigator Global Aesthetic Improvement
Visit 3/Week 4
|
-0.02 score on a scale
Standard Deviation 0.14
|
—
|
|
Investigator Global Aesthetic Improvement
Visit 4/Week 12
|
-0.01 score on a scale
Standard Deviation 0.18
|
—
|
|
Investigator Global Aesthetic Improvement
Visit 5/Week 24
|
0.03 score on a scale
Standard Deviation 0.17
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: at injection, Visit 2/Day 14 (± 2 days), Visit 3/Day 28 (± 2 days), Visit 4/Day 84 (± 4 days), Visit 5/Day 168 (Week 24) (± 7 days)Population: ITT (safety population): All randomized subjects who received study product
study products will be compared by evaluating the nature, severity, and frequency of treatment-emergent adverse events (TEAEs)
Outcome measures
| Measure |
Revanesse Ultra+
n=100 Participants
Revanesse Ultra+ (with lidocaine)
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
n=100 Participants
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
Safety and Tolerability of Revanesse Ultra and Revanesse Ultra+ Injection by Incidence of Treatment Emergent Adverse Events
|
112 events
|
102 events
|
Adverse Events
Revanesse Ultra+
Serious events: 0 serious events
Other events: 53 other events
Deaths: 0 deaths
Revanesse Ultra
Serious events: 1 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Revanesse Ultra+
n=100 participants at risk
Revanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
n=100 participants at risk
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Worsening Right Knee Pain (arthralgia)
|
0.00%
0/100 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
1.0%
1/100 • Number of events 1 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
Other adverse events
| Measure |
Revanesse Ultra+
n=100 participants at risk
Revanesse Ultra+ (with lidocaine) vs Revanesse Ultra without lidocaine
Revanesse Ultra+ (with lidocaine): Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
Revanesse Ultra: Comparator without lidocaine
|
Revanesse Ultra
n=100 participants at risk
Revanesse Ultra (without lidocaine)
|
|---|---|---|
|
General disorders
Injection Site Bruising
|
32.0%
32/100 • Number of events 37 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
31.0%
31/100 • Number of events 39 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
|
General disorders
Injection site pain
|
17.0%
17/100 • Number of events 19 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
21.0%
21/100 • Number of events 28 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
|
General disorders
Injection site swelling
|
21.0%
21/100 • Number of events 23 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
17.0%
17/100 • Number of events 21 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
|
General disorders
Injection site erythema
|
15.0%
15/100 • Number of events 17 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
12.0%
12/100 • Number of events 13 • Each subject was monitored for the occurrence of AEs, including SAEs, immediately after treatment initiation. Each subject was followed for safety monitoring until discharged from the study. Follow-up procedures related to pregnancy or AEs or SAEs could continue beyond the end of the study. Adverse event data was collected over a 10 month period of time.
|
Additional Information
Mr. Ario Khoshbin
Prollenium Medical Technologies Inc.
Phone: +1 (905) 508-1469
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place