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

NCT06337747 | Completed

• 1 other identifier: 04-2023-PLLA
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Temple; Poly-L-lactic acid; Aesthetic; Dermal fillers

Outcome Measures

Primary Outcomes (1)

• To access the efficacy of the tradition and experimental technique

  To assess the efficacy of poly-l-lactic acid for volumization of the temporal fossae, between standard and extended techniques at all follow-up visits.

  Baseline to Week 7, Week 14, Week 20, Week 28, Week 38

Secondary Outcomes (1)

• To access the safety of the tradition and experimental technique

  Baseline to Week 7, Week 14, Week 20, Week 28, Week 38

Study Arms (2)

Traditional technique

ACTIVE COMPARATOR

Device: Traditional technique

Extended technique

EXPERIMENTAL

Device: Experimental technique

Interventions

Traditional technique DEVICE

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

Traditional technique

Experimental technique DEVICE

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.

Extended technique

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee, prior to the initiation of any screening or study-specific procedures.
• Subjects must be adult male or female, at least 18 years old.
• Subjects must be willing and able to comply with procedures required in the protocol.
• Subjects must be in good health as per investigator's judgment based on medical history.
• Subjects must have mild to severe temporal fossa hollowing.
• Subjects must not have uncontrolled systemic disease.
• Subjects do not present with or have a history of any medical condition that may place the subject at increased risk following exposure to PLLA or interfere with the study evaluation, including:
• History of facial nerve palsy.
• Infection or dermatological condition at the treatment injection sites.
• Marked facial asymmetry, dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or excessively photodamaged skin.
• Any eyebrow or eyelid ptosis at Baseline as determined by the investigator.
• Subjects do not have history of clinically significant medical conditions or any other reason that the investigator determines would interfere with the subject's participation in this study or would make the subject an unsuitable candidate to receive study drug.
• Subjects do not have history of an allergic reaction or significant sensitivity to constituents of the study drug (or its excipients).
• Subjects must not have tattoos, jewelry, or clothing which obscure the temporal region and cannot be removed.
• Subjects do not have anticipated need for surgery or overnight hospitalization during the study.

Sponsors & Collaborators

• Erevna Innovations Inc.: lead

Study Sites (1)

Erevna Innovations Inc

Montreal, Quebec, H3R 3A1, Canada

Location

Related Publications (5)

• Chen HH, Javadi P, Daines SM, Williams EF 3rd. Quantitative assessment of the longevity of poly-L-lactic acid as a volumizing filler using 3-dimensional photography. JAMA Facial Plast Surg. 2015 Jan-Feb;17(1):39-43. doi: 10.1001/jamafacial.2014.867.

  PMID: 25340593 BACKGROUND

• Lowe NJ. Dispelling the myth: appropriate use of poly-L-lactic acid and clinical considerations. J Eur Acad Dermatol Venereol. 2006 May;20 Suppl 1:2-6. doi: 10.1111/j.1468-3083.2006.01515.x.

  PMID: 16643417 BACKGROUND

• Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006 Sep;118(3 Suppl):46S-54S. doi: 10.1097/01.prs.0000234846.00139.74.

  PMID: 16936544 BACKGROUND

• Vleggaar D, Fitzgerald R, Lorenc ZP. Composition and mechanism of action of poly-L-lactic acid in soft tissue augmentation. J Drugs Dermatol. 2014 Apr;13(4 Suppl):s29-31.

  PMID: 24719074 BACKGROUND

• Ali A. Contouring of the gluteal region in women: enhancement and augmentation. Ann Plast Surg. 2011 Sep;67(3):209-14. doi: 10.1097/SAP.0b013e318206595b.

  PMID: 21587056 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized-controlled trial

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: March 29, 2024
• Study Start: May 19, 2023
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: August 5, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)