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

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

Study Overview

• Status: Completed
• Conditions: Lip Augmentation
• Intervention / Treatment: Device: PN40082

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

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • California Dermatology & Clinical Research Institute
  • Florida
    • Miami, Florida, United States, 33144
      • International Dermatology Research, INC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New York
    • New York, New York, United States, 10022
      • Schweiger Dermatology, PLLC
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Plano, Texas, United States, 75093
      • Skintastic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PN40082; All subjects in this study will receive one open-label treatment with PN40082.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Prollenium Medical Technologies Inc.
• Collaborators: Symbio, LLC
• Investigators: Principal Investigator: Stacy R. Smith, MD, California Dermatology & Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2018
• Primary Completion (ACTUAL): August 27, 2019
• Study Completion (ACTUAL): August 27, 2019

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (ACTUAL): July 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PRO 2018-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes