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

Prollenium Medical Technologies Inc.84 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lip Augmentation

Interventions

PN40082DEVICE

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.

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. 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 3. Willing to give written informed consent Exclusion Criteria: 1\. Women who are pregnant, lactating, or planning a pregnancy

Locations (6)

California Dermatology & Clinical Research Institute

Encinitas, California, United States

International Dermatology Research, Inc

Miami, Florida, United States

Skin Specialists, PC

Omaha, Nebraska, United States

Schweiger Dermatology, PLLC

New York, New York, United States

Outcomes

Primary Outcomes

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)

Time frame: 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).

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

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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)

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

Data from ClinicalTrials.gov

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