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

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of retreatment with PN40082 for lip augmentation.

Detailed Description
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This is a multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation who received treatment with either PN40082 or Restylane Silk in prior Protocol PRO 2018-02 (NCT04032977). Subjects meeting the inclusion/exclusion criteria will receive a single additional treatment with PN40082

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

Conditions
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Lip Augmentation

Intervention / Treatment
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* Device: PN40082


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In Protocol PRO 2018-02, the subject was in the per-protocol population, i.e., 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, and had no significant protocol violations that would affect the treatment evaluation. If female and of childbearing potential, a negative urine pregnancy test at Visit 1/Day 1 and the subject agrees to use adequate contraception during the study period Willing to give written informed consent Exclusion Criteria: 1. Women who are pregnant, lactating, or planning a pregnancy

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: multicenter, open-label clinical study of retreatment of subjects seeking lip augmentation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PN40082<br>All subjects in this study will receive one open-label treatment with PN40082. | Device: PN40082<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Lip Fullness Grading Scale | 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) | Visit 1/Day 1 to Visit 3/Month 2, 56 Days | 
| Change From Baseline in Perioral Lines Severity Scale | 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). | Visit 1/Day 1 to Visit 3/Month 2, 56 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Patient Global Aesthetic Improvement | 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) | Visit 1/Day 1 to Visit 3/Month 2, 56 days | 
| Number of Participants With Investigator Global Aesthetic Improvement | 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) | Visit 1/Day 1 to Visit 3/Month 2, 56 days | 
| Number of Subjects With Decreased Swelling | Swelling Assessment at Visit 3/Month 2, a 4 point scale with 0 = no swelling (better outcome) up to 4= Severe Swelling (worse outcome) | Visit 1/Day 1 to Visit 3/Month 2, 56 days |