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Completed

NCT Number: NCT04029519

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.

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Key information

Conditions

Lip Augmentation

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

California Dermatology & Clinical Research Institute, Encinitas, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Women who are pregnant, lactating, or planning a pregnancy

Treatment and study plan

PN40082

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.

Primary outcomes

  1. Change From Baseline in Lip Fullness Grading Scale

    Time frame: 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)

  2. Change From Baseline in Perioral Lines Severity Scale

    Time frame: 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 outcomes

  1. Number of Participants With Patient Global Aesthetic Improvement

    Time frame: 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)

  2. Number of Participants With Investigator Global Aesthetic Improvement

    Time frame: 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)

  3. Number of Subjects With Decreased Swelling

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Prollenium Medical Technologies Inc.

Industry

Collaborators

  • Symbio, LLC

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2019
Registry last updated
Jul 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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