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

Phase 3

Completed

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

Detailed Description: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PN40082	PN40082	All subjects in this study will receive one open-label treatment with PN40082.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Lip Fullness Grading Scale	Visit 1/Day 1 to Visit 3/Month 2, 56 Days	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)
Change From Baseline in Perioral Lines Severity Scale	Visit 1/Day 1 to Visit 3/Month 2, 56 Days	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).

Secondary Outcome Measures

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

Locations (6): International Dermatology Research, Inc
🇺🇸
Miami, Florida, United States
Tennessee Clinical Research Center
🇺🇸
Nashville, Tennessee, United States
Schweiger Dermatology, PLLC
🇺🇸
New York, New York, United States
California Dermatology & Clinical Research Institute
🇺🇸
Encinitas, California, United States
Skin Specialists, PC
🇺🇸
Omaha, Nebraska, United States
Skintastic
🇺🇸
Plano, Texas, United States