Trial Outcomes & Findings for A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation (NCT NCT04029519)

Last Updated: 2021-07-14

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

84 participants

Primary outcome timeframe

Visit 1/Day 1 to Visit 3/Month 2, 56 Days

Results posted on

2021-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	PN40082 All subjects in this study will receive one open-label treatment with PN40082.
Overall Study STARTED	84
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	PN40082 All subjects in this study will receive one open-label treatment with PN40082.
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PN40082 n=84 Participants All subjects in this study will receive one open-label treatment with PN40082. 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.
Age, Continuous	50 years n=93 Participants
Sex: Female, Male Female	82 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	12 Participants n=93 Participants
Race (NIH/OMB) White	70 Participants n=93 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants

PRIMARY outcome

Timeframe: Visit 1/Day 1 to Visit 3/Month 2, 56 Days

Population: Change from Baseline in Overall Lips Fullness Grading Scale at Visit3/Month 2.

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

Outcome measures

Outcome measures
Measure	PN40082 n=79 Participants All subjects in this study will receive one open-label treatment with PN40082. 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.
Change From Baseline in Lip Fullness Grading Scale	.82 score on a scale Standard Deviation 0.747

PRIMARY outcome

Timeframe: Visit 1/Day 1 to Visit 3/Month 2, 56 Days

Population: Change from baseline to Visit 3/Month 2 in the perioral lines rating scale for the 17 subjects who had perioral lines treated.

Change from baseline in the perioral lines rating scale (POL), a 4 point rating scale with 0 as a mouth with no perioral lines (better outcome) to 3 a mouth with many deep lines or crevices (worse outcome).

Outcome measures

Outcome measures
Measure	PN40082 n=17 Participants All subjects in this study will receive one open-label treatment with PN40082. 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.
Change From Baseline in Perioral Lines Severity Scale	-0.75 score on a scale Standard Deviation 0.577

SECONDARY outcome

Timeframe: Visit 1/Day 1 to Visit 3/Month 2, 56 days

Population: Change from baseline in the Patient Global Aesthetic Improvement scale with 5 being much improved optimal cosmetic results (better outcome) and 1 being the appearance is worse than the original condition (worse outcome)

Change from baseline for the patient Global Aesthetic Improvement scale, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 very much improved optimal cosmetic result (better outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=79 Participants All subjects in this study will receive one open-label treatment with PN40082. 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.
Number of Participants With Patient Global Aesthetic Improvement Very much Improved (5)	41 Participants
Number of Participants With Patient Global Aesthetic Improvement Much Improved (4)	19 Participants
Number of Participants With Patient Global Aesthetic Improvement Improved (3)	17 Participants
Number of Participants With Patient Global Aesthetic Improvement No change (2)	2 Participants
Number of Participants With Patient Global Aesthetic Improvement Worse (1)	0 Participants

SECONDARY outcome

Timeframe: Visit 1/Day 1 to Visit 3/Month 2, 56 days

Population: Change from baseline in the Investigator Global Aesthetic Improvement score with 1 being appearance is worse than the original condition (worse outcome) up to 5 being very much improved optimal cosmetic result (better outcome)

Change from baseline in the Investigator Global Aesthetic Improvement score, a 5 point scale with 1= the appearance is worse than the original condition (worse outcome) up to 5 = very much improved optimal cosmetic result (better outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=79 Participants All subjects in this study will receive one open-label treatment with PN40082. 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.
Number of Participants With Investigator Global Aesthetic Improvement Very Much Improved (5)	28 Participants
Number of Participants With Investigator Global Aesthetic Improvement Much Improved (4)	30 Participants
Number of Participants With Investigator Global Aesthetic Improvement Improved (3)	20 Participants
Number of Participants With Investigator Global Aesthetic Improvement No Change (2)	1 Participants
Number of Participants With Investigator Global Aesthetic Improvement Worse (1)	0 Participants

SECONDARY outcome

Timeframe: Visit 1/Day 1 to Visit 3/Month 2, 56 days

Population: Swelling assessment at Visit 3/Month 2 with 0 = no swelling (better outcome) up to 4 = severe swelling (worse outcome)

Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome)

Outcome measures

Outcome measures
Measure	PN40082 n=79 Participants All subjects in this study will receive one open-label treatment with PN40082. 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.
Number of Subjects With Decreased Swelling	79 Participants

Adverse Events

PN40082

Serious events: 1 serious events

Other events: 61 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PN40082 n=84 participants at risk All subjects in this study will receive one open-label treatment with PN40082. 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.
Infections and infestations Beta Hemolytic Streptococcal Infection	1.2% 1/84 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.
Gastrointestinal disorders Stenosis in Sigmoid Colon	1.2% 1/84 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.

Other adverse events

Other adverse events
Measure	PN40082 n=84 participants at risk All subjects in this study will receive one open-label treatment with PN40082. 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.
General disorders Injection Site Bruising	47.6% 40/84 • Number of events 40 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.
General disorders Injection Site Erythema	7.1% 6/84 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.
General disorders Injection site mass	7.1% 6/84 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.
General disorders Injection site pain	11.9% 10/84 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.
General disorders Injection Site Swelling	57.1% 48/84 • Number of events 48 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 6 months.
Musculoskeletal and connective tissue disorders Facial Asymmetry	6.0% 5/84 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent until discharged from the study, approximately 3 months. Follow-up procedures related to pregnancy, AEs, SAEs or AESIs could continue beyond the end of the study, an average of 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