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Comparing Injections With Poly-L-Lactic Acid in the Temporal Fossa vs. Extended Temporal Fossa + Hairline

NCT06337747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-08-05

No results posted yet for this study

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.

Conditions

  • Aging

Interventions

DEVICE

Traditional technique

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

DEVICE

Experimental technique

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.

Sponsors & Collaborators

  • Erevna Innovations Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2024-04-23
Completion
2024-04-23

Countries

  • Canada

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 NCT06337747 on ClinicalTrials.gov