Trial Outcomes & Findings for A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation (NCT NCT04029545)
NCT ID: NCT04029545
Last Updated: 2021-08-20
Results Overview
Compare subject pain scores with a 100 mm visual analog scale with 00 being no pain (better outcome) and 100 being worst possible pain (worse outcome)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
5 participants
Primary outcome timeframe
Visit 1/Day 1 through Visit 2/Month 1, 28 days
Results posted on
2021-08-20
Participant Flow
Participant milestones
| Measure |
PN40082
PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
|
RV001 With Lidocaine Cream
RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used with LMX4, a topical lidocaine.
|
RV001
RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used alone.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter, Double-blind, Randomized, Controlled, Roll-over Retreatment Study of the Safety and Pain Associated With Injections of PN40082, RV001 With Topical Anesthetic or RV001 for Lip Augmentation
Baseline characteristics by cohort
| Measure |
PN40082
n=2 Participants
PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
|
RV001 With Lidocaine Cream
n=1 Participants
RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used with LMX4, a topical lidocaine.
|
RV001
n=2 Participants
RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used alone.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.5 years
n=5 Participants
|
55 years
n=7 Participants
|
58 years
n=5 Participants
|
54.4 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Visit 1/Day 1 through Visit 2/Month 1, 28 daysCompare subject pain scores with a 100 mm visual analog scale with 00 being no pain (better outcome) and 100 being worst possible pain (worse outcome)
Outcome measures
| Measure |
PN40082
n=2 Participants
PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
|
RV001 With Lidocaine Cream
n=1 Participants
RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used with LMX4, a topical lidocaine.
|
RV001
n=2 Participants
RV001 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid to be used alone.
|
|---|---|---|---|
|
Number of Participants With Improved Pain Score From Baseline at Visit 2
|
2 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
PN40082
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RV001 With Lidocaine Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RV001
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director Clinical Affairs
Prollenium Medical Technologies
Phone: 19055081469
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place