CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Traditional technique +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/NCT06337747
NCT06337747N/ACompleted

A Prospective, Randomized-controlled Trial Comparing Superficial Injections With Poly-L-Lactic Acid in the Temporal Fossa Versus Extended Temporal Fossa + Hairline

Erevna Innovations Inc.·interventional·Posted Mar 29, 2024·Updated Aug 5, 2024

In Brief

A clinical study evaluating Traditional technique and Experimental technique for Aging. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The use of poly-L-Lactic acid (PLLA) has demonstrated significant improvement in multiple facial and body regions. Its use in the temporal fossa is the ideal location to demonstrate its impact on neocollagenesis given its distinct anatomic boundaries. Furthermore, the fact that the lateral boundary of the temporal region can extend into the hairline allows for a graded effect to be measured. Therefore, this study aims to extend these findings by evaluating the efficacy and safety of two injection techniques for volumizing temporal hollows.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAging
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMar 29, 2024
Enrollment StartMay 19, 2023
Primary CompletionApr 23, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.3 years ago

Interventions

Traditional techniquedevice

Subjects randomized to the traditional technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region.

Experimental techniquedevice

Subjects randomized to the extended technique will receive 3cc of PLLA (per side, per treatment) in the anterior temporal region, as well as 2cc (per side, per treatment) in the posterior (i.e., behind the hairline) temporal region.