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Safety and Effectiveness of PN40082 for Lip Augmentation

NCT04032977 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2021-07-12

Study results available
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Summary

To compare the safety and efficacy profile of PN40082 versus Restylane Silk Injectable Gel with 0.3% lidocaine (Restylane Silk) for lip augmentation in approximately 158 subjects.

Conditions

  • Lip Augmentation

Interventions

DEVICE

PN40082

To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips

DEVICE

Restylane Silk

To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips

Sponsors & Collaborators

  • Symbio, LLC

    collaborator INDUSTRY

  • Prollenium Medical Technologies Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2019-05-03
Completion
2019-05-03

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 NCT04032977 on ClinicalTrials.gov