Trial Outcomes & Findings for Safety and Effectiveness of PN40082 for Lip Augmentation (NCT NCT04032977)

Last Updated: 2021-07-12

Results Overview

The Lip Fullness Grading Scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 being full lips (better outcome)

Recruitment status

COMPLETED

Target enrollment

158 participants

Primary outcome timeframe

Visit 1 baseline to Visit 3 Month 2, 56 days

Results posted on

2021-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	PN40082 Test device: 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	Restylane Silk Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Overall Study STARTED	80	78
Overall Study COMPLETED	71	70
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Reasons for withdrawal
Measure	PN40082 Test device: 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	Restylane Silk Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Overall Study Withdrawal by Subject	6	1
Overall Study Lost to Follow-up	2	7
Overall Study Pregnancy	1	0

Baseline Characteristics

Safety and Effectiveness of PN40082 for Lip Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PN40082 n=80 Participants Test device: 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	Restylane Silk n=78 Participants Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.	Total n=158 Participants Total of all reporting groups
Age, Continuous	45.6 years STANDARD_DEVIATION 11.85 • n=5 Participants	49.2 years STANDARD_DEVIATION 11.85 • n=7 Participants	47.4 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	76 Participants n=7 Participants	156 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	18 Participants n=7 Participants	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=5 Participants	60 Participants n=7 Participants	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants	61 Participants n=7 Participants	126 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 1 baseline to Visit 3 Month 2, 56 days

Population: Per-Protocol population is all randomized subjects who met all inclusion/exclusion criteria; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2 within the specified visit window, and had no significant protocol violations that would affect the treatment evaluation.

The Lip Fullness Grading Scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) up to 4 being full lips (better outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=54 Participants Test device: 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	Restylane Silk n=55 Participants Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Change in Overall Lip Fullness Grading Scale	1.52 score on a scale Standard Deviation .885	1.53 score on a scale Standard Deviation .790

SECONDARY outcome

Timeframe: Visit 1 baseline to Visit 3 Month 2, 56 days

Population: Per-protocol population is all randomized subjects who met all inclusion/exclusion criteria; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2 within the specified visit window, and had no significant protocol violations that would affect the treatment evaluation

Percent of subjects with Lip Fullness treatment success (responder: overall LFGS based on the Blinded Evaluating Investigator Assessment) at Visit 3/Month 2 where responder is defined as a subject with at least a 1-grade increase from baseline on the LFGS post augmentation The lip fullness grading scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) to 4 being full lips (better outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=54 Participants Test device: 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	Restylane Silk n=55 Participants Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Treatment Success Lip Fullness Grading Scale	49 Participants	51 Participants

SECONDARY outcome

Timeframe: Visit 1 baseline to Visit 4 Month 3, 84 days

Population: Per Protocol population is all randomized subjects who met all inclusion/exclusion criteria; received study device, completed Visit 5 within the specified window; had LFGS score by the Blinded Evaluating Investigator at Visit 3/Month 2 within the specified visit window, and had no significant protocol violations that would affect the treatment evaluation. Of the per protocol population the subjects who had perioral injection at Visit 1 or Visit 2 and had POL assessed at Visit 4/Month 3

Percent of responders with Perioral Lines Treatment Success overall on the POL severity scale at Visit 4/Month 3 (defined as a subject demonstrating ≥ 1-point improvement, i.e., decrease in severity, from baseline. The Perioral Lines at rest severity scale is a 4 point rating scale with 0 = None, a mouth with no perioral lines (better outcome) to 3 = Severe, being a mouth with many deep lines or crevices (worse outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=21 Participants Test device: 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	Restylane Silk n=21 Participants Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Treatment Success Perioral Lines Severity Scale	14 Participants	12 Participants

SECONDARY outcome

Timeframe: Visit 1 baseline to Visit 4 Month 3, 84 days

The lip fullness grading scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) to 4 being full lips (better outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=54 Participants Test device: 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	Restylane Silk n=55 Participants Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Change From Baseline to Visit 4/Month 3 in Overall Lip Fullness Grading Scale	1.37 score on a scale Standard Deviation .917	1.42 score on a scale Standard Deviation .712

SECONDARY outcome

Timeframe: Visit 1 baseline to Visit 5 Month 6, 168 days

The lip fullness grading scale is a 5 point photonumeric rating scale with 0 being very thin lips (worse outcome) to 4 being full lips (better outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=54 Participants Test device: 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	Restylane Silk n=55 Participants Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Change From Baseline to Visit 5/Month 6 in Overall Lip Fullness Grading Scale	1.00 score on a scale Standard Deviation .727	.93 score on a scale Standard Deviation .634

Adverse Events

PN40082

Serious events: 2 serious events

Other events: 75 other events

Deaths: 0 deaths

Restylane Silk

Serious events: 1 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PN40082 n=80 participants at risk Test device: 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	Restylane Silk n=78 participants at risk Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
Eye disorders Detached Retina Right Eye	1.2% 1/80 • Number of events 1 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	0.00% 0/78 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Right Invasive Mammary Carcinoma, Stage 2	1.2% 1/80 • Number of events 1 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	0.00% 0/78 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
Nervous system disorders Facial Paralysis	0.00% 0/80 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	1.3% 1/78 • Number of events 1 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.

Other adverse events

Other adverse events
Measure	PN40082 n=80 participants at risk Test device: 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	Restylane Silk n=78 participants at risk Restylane Silk (manufactured by Q-Med AB for Medicis - A Division of Valeant Pharmaceuticals Corporation North America, LLC ) is a clear, colorless gel in 1.0 mL pre-filled syringes formulated to a concentration of 20 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
General disorders Injection Site Bruising	71.2% 57/80 • Number of events 57 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	56.4% 44/78 • Number of events 44 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
General disorders Injection Site Erythema	10.0% 8/80 • Number of events 8 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	10.3% 8/78 • Number of events 8 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
General disorders Injection Site Mass	7.5% 6/80 • Number of events 6 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	11.5% 9/78 • Number of events 9 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
General disorders Injection Site Movement Impairment	3.8% 3/80 • Number of events 3 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	7.7% 6/78 • Number of events 6 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
General disorders Injection Site Pain	21.2% 17/80 • Number of events 17 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	30.8% 24/78 • Number of events 24 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
General disorders Injection Site Pruritus	5.0% 4/80 • Number of events 4 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	3.8% 3/78 • Number of events 3 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
General disorders Injection Site Swelling	87.5% 70/80 • Number of events 70 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	89.7% 70/78 • Number of events 70 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
Musculoskeletal and connective tissue disorders Facial Asymmetry	15.0% 12/80 • Number of events 12 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	10.3% 8/78 • Number of events 8 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.
Nervous system disorders Headache	1.2% 1/80 • Number of events 1 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.	10.3% 8/78 • Number of events 8 • Each subject was monitored for the occurrence of AEs, including serious adverse events (SAEs), starting immediately after the subject has signed the informed consent form (ICF). Each subject was followed for safety monitoring until he/she was discharged from the study, up to 6 months. No Follow-up procedures related to pregnancy, AEs, or SAEs continued beyond the end of the study, 6 months.

Additional Information

Director Clinical Affairs

Prollenium Medical Technologies

Phone: 1-905-508-1469

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place