A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Volyme in the Treatment of Temple Hollowing

Galderma R&D1 site in 1 country162 target enrollmentNovember 18, 2024

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Galderma R&D
Enrollment: 162
Locations: 1
Primary Endpoint: Responder Rate on a Temple Hollowing Scale
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane Volyme in the treatment of temple hollowing

Registry

clinicaltrials.gov

Start Date

November 18, 2024

End Date

July 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Galderma R&D

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
•Males or non-pregnant, non-breastfeeding females of Chinese origin and 18 years of age or older at the time of signing the Informed Consent Form (ICF).
•Grade 2 (moderate) to 3 (severe) on the 4-grade GTVDS for both temples as assessed by the Blinded Evaluator as well as the Treating Investigator on Day 1 (agreement on grade is not required). The GTVDS grade for the right temple and the left temple does not have to be equal but must not differ by more than 1 grade.
•Willing to abstain from any other facial plastic surgical or cosmetic procedures above the level of the horizontal line from subnasale for the duration of the study (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
•Intent to undergo treatment for correction of temple hollowing.
•Inclusion criteria 6-7 apply to female subjects only:
•If the subject is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) or a serum HCG (blood test \[if UPT is not available\]) at screening, baseline and prior to receiving any study treatment.
•Acceptable forms of effective birth control include:
•Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical caps) with spermicidal foam/gel/film/cream/suppository;
•Bilateral tubal ligation;

Exclusion Criteria

•Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
•Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject).
•Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
•Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments.
•Any previous aesthetic procedures or implants:
•Previous permanent filler or implant, lifting threads, or autologous fat in the face regardless of time.
•Previous use of calcium hydroxylapatite (CaHA) or poly-L-lactic acid (PLLA) above the level of the horizontal line from subnasale within 24 months.
•Previous HA filler or collagen filler above the level of the horizontal line from subnasale within 12 months.
•Previous botulinum toxin treatment above the level of the horizontal line from subnasale within 6 months.
•Previous energy based aesthetic procedures (e.g., laser, intense pulsed light, radiofrequency, photomodulation and ultrasound) above the level of the horizontal line from subnasale within 6 months.

Outcomes

Primary Outcomes

Responder Rate on a Temple Hollowing Scale

Time Frame: 6 months

A treatment responder is defined as a participant with at least a one-grade improvement from baseline on both temples concurrently on the Galderma Temple Volume Deficit Scale (GTVDS, a 4-grade scale rangings are none (0), mild (1), moderate (2), severe (3) temple hollowing) as assessed by the Blinded Evaluator at 6 months after last treatment for the Treatment group and 6 months after baseline for the Control group.