Safety and Effectiveness of PN40082 for Lip Augmentation

• Sponsor: Prollenium Medical Technologies Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04032977
• Collaborator: Symbio, LLC (Industry)
• Enrollment: 158
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.7
• Patients Per Site Per Month: 16.4

Study Details

Study Description

Brief Summary

To compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation in approximately 158 subjects.

Condition or Disease	Intervention/Treatment	Phase
Lip Augmentation	Device: PN40082; Device: Restylane Silk

Detailed Description

The objective of the study is to compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation. Approximately 158 subjects will be randomized at approximately 7 sites in this is a double-blind, randomized, controlled, multicenter clinical study of subjects seeking lip augmentation. Subjects meeting inclusion/exclusion criteria will be randomized 1:1 to treatment with either PN40082 or Restylane Silk. The Evaluating Investigator will be blinded to the treatment. Injections of the study device will be performed by an unblinded Treating Investigator.

At each visit, the blinded Evaluating Investigator evaluations and subject evaluations of the treated areas will be performed and recorded. Visits and telephone contacts will occur at:

Visit 1 / Week 0 (Day 1) - baseline and treatment

• Day 3 (±2 days) - Safety follow-up telephone call

• Day 14 (±2 days) - Safety follow-up telephone call Visit 2 / Day 28 (±2 days) / Month 1

• interim visit (touch-up if necessary)

• Day 33 (±2 days) - Safety follow-up telephone call (for subjects with touch-up treatment

• Day 44 (±2 days) - Safety follow-up telephone call (for subjects with touch-up treatment) Visit 3 / Day 56 (±4 days) / Month 2 - interim visit Visit 4 / Day 84 (±4 days) / Month 3 - interim visit

• Day 112 (±4 days) / Month 4 - Safety follow-up telephone call

• Day 140 (±4 days) / Month 5 - Safety follow-up telephone call Visit 5 / Day 168 (±7 days) / Month 6 - End of Study (EOS) Visit. All subjects will undergo the consent procedure for the open label retreatment protocol.

Evaluations include:

Lip Fullness Grading Scale (LFGS) (Overall lip fullness considering both lips together, fullness of the upper lip and fullness of the lower lip) Perioral lines at rest severity scale (POL) (Overall perioral lines at rest severity considering both lips together, perioral lines at rest severity of the upper lip and perioral lines at rest severity of the lower lip) Patient Global Aesthetic Improvement (pGAI) Investigator Global Aesthetic Improvement (iGAI) Safety will be assessed by monitoring adverse events (AEs) at all study visits

Other Safety Evaluations include:

Lip Function Lip Sensation

Other evaluations include:

Investigator Ease of Use Assessment Swelling Assessment Subject Satisfaction with Lips Assessment Subjects participation will be approximately 6 months and the study is estimated to last 20 months from first subject first visit to last subject last visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double-blind, randomized, controlled, multicenter clinical studyDouble-blind, randomized, controlled, multicenter clinical study
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Only the unblinded treating investigator and unblinded assistant will be unblinded to the treatment. The remainder of study/site personnel remain blinded.
• Primary Purpose: Treatment
• Official Title: A Multicenter, Double-blind, Randomized, Controlled Study of the Safety and Effectiveness of PN40082 for Lip Augmentation
• Actual Study Start Date: Jul 13, 2018
• Actual Primary Completion Date: May 3, 2019
• Actual Study Completion Date: May 3, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: PN40082; To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips; Device: Restylane Silk; To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips
Active Comparator: 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.	Device: PN40082; To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips; Device: Restylane Silk; To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips

Outcome Measures

Primary Outcome Measures

1. Change in Overall Lip Fullness Grading Scale [Visit 1 baseline to Visit 3 Month 2, 56 days]

   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)

Secondary Outcome Measures

1. Treatment Success Lip Fullness Grading Scale [Visit 1 baseline to Visit 3 Month 2, 56 days]

   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)

2. Treatment Success Perioral Lines Severity Scale [Visit 1 baseline to Visit 4 Month 3, 84 days]

   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)

3. Change From Baseline to Visit 4/Month 3 in Overall Lip Fullness Grading Scale [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)

4. Change From Baseline to Visit 5/Month 6 in Overall Lip Fullness Grading Scale [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Men or non-pregnant or non-breastfeeding women over 21 years of age

2. If female and of childbearing potential, a negative urine pregnancy test at Baseline (Day 1) and the subject agrees to use adequate contraception during the study period

3. Has an overall score of very thin, or thin on the LFGS, as agreed upon by the Treating and Evaluating Investigators, and desires at least a 1-point improvement in overall LFGS score; OR Has a Fitzpatrick skin phototype IV, V or VI and has an LFGS score of thick or full, as agreed upon by the Treating and Evaluating Investigators, and desires treatment to the vermilion body of 1 or both lips

4. Willing to give written informed consent

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning a pregnancy

2. History of allergy, anaphylaxis or hypersensitivity to injectable hyaluronic acid products, local anesthetics of the amide type such as lidocaine, or to latex, or is planning to undergo desensitization therapy during the study

3. Has lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area for the effectiveness assessments

4. Has abnormal lip function, with inability to effectively sip water through a straw

5. Has abnormal lip sensation, with inability to feel a 0.4G monofilament or a cotton wisp at any site on the lip

6. Has moderate or severe abnormal lip asymmetry

7. Has any mass formation on the lip

8. Has dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities as judged by the Treating Investigator. Subjects planning to undergo extensive dental procedures such as dental implants, multiple tooth extractions, or oral surgery should not participate. Minor dental procedures such as teeth cleaning and repair of caries are not exclusionary

9. Has undergone facial plastic surgery or received permanent facial implants (e.g., polymethylmethacrylate, silicone, polytetrafluoroethylene, polyacrylamide, lifting threads) anywhere in the face or neck, or is planning to be implanted with any of these products during the study

10. Has undergone semi-permanent dermal filler treatment (e.g., calcium hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 12 months before enrollment or is planning to undergo such treatment during the study

11. Has undergone facial tissue augmentation with fat injections, botulinum toxin injections in the lower face (below the orbital rim), mesotherapy, or cosmetic procedures in the face or neck (e.g., face-lift, laser, photo-modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, microneedling, or other ablative procedures) within 9 months before enrollment or is planning to undergo any of these procedures during the study

12. Has used ANY lip filling agents within 12 months of study enrollment (hyaluronic acid products, collagen-based products, etc.)

13. Has used any lip plumping products or devices within 10 days before enrollment or is planning to use such products during the study

14. Has begun using any over-the-counter (OTC) or prescription oral or topical anti wrinkle products for the lips or around the mouth within 90 days before enrollment or is planning to begin using such products during the study (Subjects who have been on a stable regimen of such products for at least 90 days are eligible for the study and must continue their regimen throughout the study.)

15. Is on an ongoing regimen of anticoagulation therapy (e.g., warfarin), thrombolytics, or inhibitors of platelet aggregation or nonsteroidal anti inflammatory drugs (NSAIDs, e.g., aspirin, ibuprofen) or other substances known to increase coagulation time (e.g., herbal supplements with garlic or gingko) within 10 days of undergoing study device injections. Subjects who will withhold such therapy for 10 days before AND after any injection session may participate

16. Has a history or presence of bleeding disorders

17. Has used systemic corticosteroids or immunosuppressive medications within 30 days prior to treatment

18. Is on a concurrent regimen of lidocaine or structurally related local anesthetics (e.g., bupivacaine)

19. Has an active inflammation (skin eruptions such as cysts, pimples, rashes, or hives), infection, cancerous or precancerous lesion, or unhealed wound on the face

20. Has a history of known susceptibility to keloid formation or hypertrophic scars

21. Has porphyria

22. Has active herpes labialis lesions at the time of injections. Subjects with a history of herpes labialis who have had four (4) or more outbreaks in the 12 months prior to enrollment are also excluded even in the absence of lesions at the baseline visit

23. Has impaired cardiac conduction, severely impaired hepatic function, or severe renal dysfunction that, in the opinion of the investigator, would place them at risk of associated complications from these illnesses during the course of the study

24. Has any uncontrolled disease, i.e., a condition that has not been appropriately diagnosed, evaluated, and received medically appropriate treatment or care

25. Has severe cardiovascular disease; examples include but are not limited to New York Heart Association heart failure classification III or IV, unstable angina, and internal pacemakers. Potential subjects with other significant cardiovascular diseases should be discussed with the Medical Monitor before enrolling-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tennessee Clinical Research Center	Nashville	Tennessee	United States	37215

Sponsors and Collaborators

• Prollenium Medical Technologies Inc.
• Symbio, LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Oct 2, 2018
• Statistical Analysis Plan - May 9, 2018

More Information

Publications

None provided.

• Responsible Party: Prollenium Medical Technologies Inc.
• ClinicalTrials.gov Identifier: NCT04032977
• Other Study ID Numbers: PRO 2018-02
• First Posted: Jul 25, 2019
• Last Update Posted: Jul 12, 2021
• Last Verified: May 1, 2021

Study Results

Participant Flow

Arm/Group Title	PN40082	Restylane Silk
Arm/Group Description	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 (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.
Period Title: Overall Study
STARTED	80	78
COMPLETED	71	70
NOT COMPLETED	9	8

Baseline Characteristics

Arm/Group Title	PN40082	Restylane Silk	Total
Arm/Group Description	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 (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 of all reporting groups
Overall Participants	80	78	158
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.6 (11.85)	49.2 (11.85)	47.4 (11.94)
Sex: Female, Male (Count of Participants)
Female	80 100%	76 97.4%	156 98.7%
Male	0 0%	2 2.6%	2 1.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	26 32.5%	18 23.1%	44 27.8%
Not Hispanic or Latino	54 67.5%	60 76.9%	114 72.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.3%	0 0%	1 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	12 15%	15 19.2%	27 17.1%
White	65 81.3%	61 78.2%	126 79.7%
More than one race	0 0%	2 2.6%	2 1.3%
Unknown or Not Reported	2 2.5%	0 0%	2 1.3%

Outcome Measures

1. Primary Outcome

Title	Change in Overall Lip Fullness Grading Scale
Description	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)
Time Frame	Visit 1 baseline to Visit 3 Month 2, 56 days

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	PN40082	Restylane Silk
Arm/Group Description	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 (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.
Measure Participants	54	55
Mean (Standard Deviation) [score on a scale]	1.52 (.885)	1.53 (.790)

2. Secondary Outcome

Title	Treatment Success Lip Fullness Grading Scale
Description	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)
Time Frame	Visit 1 baseline to Visit 3 Month 2, 56 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PN40082	Restylane Silk
Arm/Group Description	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 (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.
Measure Participants	54	55
Count of Participants [Participants]	49 61.3%	51 65.4%

3. Secondary Outcome

Title	Treatment Success Perioral Lines Severity Scale
Description	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)
Time Frame	Visit 1 baseline to Visit 4 Month 3, 84 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PN40082	Restylane Silk
Arm/Group Description	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 (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.
Measure Participants	21	21
Count of Participants [Participants]	14 17.5%	12 15.4%

4. Secondary Outcome

Title	Change From Baseline to Visit 4/Month 3 in Overall Lip Fullness Grading Scale
Description	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)
Time Frame	Visit 1 baseline to Visit 4 Month 3, 84 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PN40082	Restylane Silk
Arm/Group Description	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 (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.
Measure Participants	54	55
Mean (Standard Deviation) [score on a scale]	1.37 (.917)	1.42 (.712)

5. Secondary Outcome

Title	Change From Baseline to Visit 5/Month 6 in Overall Lip Fullness Grading Scale
Description	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)
Time Frame	Visit 1 baseline to Visit 5 Month 6, 168 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PN40082	Restylane Silk
Arm/Group Description	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 (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.
Measure Participants	54	55
Mean (Standard Deviation) [score on a scale]	1.00 (.727)	.93 (.634)

Adverse Events

Time Frame	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.
Arm/Group Title	PN40082		Restylane Silk
Arm/Group Description	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 (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.
All Cause Mortality
	PN40082		Restylane Silk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		0/78 (0%)
Serious Adverse Events
	PN40082		Restylane Silk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/80 (2.5%)		1/78 (1.3%)
Eye disorders
Detached Retina Right Eye	1/80 (1.3%)	1	0/78 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Right Invasive Mammary Carcinoma, Stage 2	1/80 (1.3%)	1	0/78 (0%)	0
Nervous system disorders
Facial Paralysis	0/80 (0%)	0	1/78 (1.3%)	1
Other (Not Including Serious) Adverse Events
	PN40082		Restylane Silk
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	75/80 (93.8%)		75/78 (96.2%)
General disorders
Injection Site Bruising	57/80 (71.3%)	57	44/78 (56.4%)	44
Injection Site Erythema	8/80 (10%)	8	8/78 (10.3%)	8
Injection Site Mass	6/80 (7.5%)	6	9/78 (11.5%)	9
Injection Site Movement Impairment	3/80 (3.8%)	3	6/78 (7.7%)	6
Injection Site Pain	17/80 (21.3%)	17	24/78 (30.8%)	24
Injection Site Pruritus	4/80 (5%)	4	3/78 (3.8%)	3
Injection Site Swelling	70/80 (87.5%)	70	70/78 (89.7%)	70
Musculoskeletal and connective tissue disorders
Facial Asymmetry	12/80 (15%)	12	8/78 (10.3%)	8
Nervous system disorders
Headache	1/80 (1.3%)	1	8/78 (10.3%)	8

Limitations/Caveats

Due to blinded randomization, no men were randomized into the PN40082 group. Pooled analysis was provided to the FDA from previous studies to demonstrate safety in men. Not enough subjects were randomized that required treatment of their perioral lines to demonstrate statistically non-inferiority.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.