CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 158 enrolled
Drug / intervention
PN40082 +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04032977
NCT04032977N/ACompleted
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A Multicenter, Double-blind, Randomized, Controlled Study of the Safety and Effectiveness of PN40082 for Lip Augmentation

Prollenium Medical Technologies Inc.·interventional·Posted Jul 25, 2019·Updated Jul 12, 2021

In Brief

A clinical study evaluating PN40082 and Restylane Silk for Lip Augmentation. Completed, enrolled 158 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLip Augmentation
CountriesUnited States
CollaboratorsSymbio, LLC

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 25, 2019
Enrollment StartJul 13, 2018
Primary CompletionMay 3, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.9 years ago

Interventions

PN40082device

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

Restylane Silkdevice

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