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

NCT04029519 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-07-14

Study results available
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Summary

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

Conditions

  • Lip Augmentation

Interventions

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.

Sponsors & Collaborators

  • Symbio, LLC

    collaborator INDUSTRY

  • Prollenium Medical Technologies Inc.

    lead INDUSTRY

Principal Investigators

  • Stacy R. Smith, MD · California Dermatology & Clinical Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2019-08-27
Completion
2019-08-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04029519 on ClinicalTrials.gov