Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

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

This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.

Study Overview

• Status: Active, not recruiting
• Conditions: Temporal Hollowing
• Intervention / Treatment: Device: Restylane Contour

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Project Manager; Phone Number: 817-961-5000; Email: aestheticclinicaltrials@galderma.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Galderma Research Site
      • Contact: Galderma R Site
  • California
    • Encino, California, United States, 91436
      • Galderma Research Site
    • Los Angeles, California, United States, 90069
      • Galderma Research Site
      • Contact: Galderma R Site
    • Redondo Beach, California, United States, 90277
      • Galderma Research Site
      • Contact: Galderma R Site
    • Solana Beach, California, United States, 92075
      • Galderma Research Site
      • Contact: Galderma R Site
    • Vista, California, United States, 92083
      • Galderma Research Site
      • Contact: Galderma R Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Galderma Research Site
      • Contact: Galderma R Site
  • Florida
    • Adventura, Florida, United States, 33180
      • Galderma Research Site
      • Contact: Galderma R Site
    • Boynton Beach, Florida, United States, 33437
      • Galderma Research Site
      • Contact: Galderma R Site
    • Coral Gables, Florida, United States, 33146
      • Galderma Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Galderma Research Site
      • Contact: Galderma R Site
  • New York
    • New York, New York, United States, 10021
      • Galderma Research Site
      • Contact: Galderma R Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Galderma Research Site
    • Wilmington, North Carolina, United States, 28405
      • Galderma Research Site
      • Contact: Galderma R Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Galderma Research Site
      • Contact: Galderma R Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males or non-pregnant, non-breastfeeding females, 22 years of age or older
• Intent to undergo treatment for correction of temple hollowing

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 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
• Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Treatment	Device: Restylane Contour; a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Responder rate based on the Blinded Evaluators' live assessment of the GTVDS	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Responder rates, as assessed by the Blinded Evaluator at 6, 9 and 12 months after baseline for the treatment group	6,9,12 months after baseline

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Study Director, Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): October 26, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 43USTH2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No