CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 84 enrolled
Drug / intervention
PN40082device
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/NCT04029519
NCT04029519Phase 3Completed
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A Multicenter, Open-Label Retreatment Study of the Safety and Effectiveness of PN40082 for Lip Augmentation

Prollenium Medical Technologies Inc.·interventional·Posted Jul 23, 2019·Updated Jul 14, 2021

In Brief

A Phase 3 clinical trial evaluating PN40082 for Lip Augmentation. Completed, enrolled 84 participants across 6 sites.

Detailed Summary

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

Study Details

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

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 23, 2019
Enrollment StartDec 21, 2018
Primary CompletionAug 27, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.9 years ago

Interventions

PN40082device

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.