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: Completed
• Conditions: Temporal Hollowing
• Intervention / Treatment: Device: Restylane Contour

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

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Galderma Research Site
  • California
    • Encino, California, United States, 91436
      • Galderma Research Site
    • Los Angeles, California, United States, 90069
      • Galderma Research Site
    • Redondo Beach, California, United States, 90277
      • Galderma Research Site
    • Solana Beach, California, United States, 92075
      • Galderma Research Site
    • Vista, California, United States, 92083
      • Galderma Research Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20037
      • Galderma Research Site
  • Florida
    • Adventura, Florida, United States, 33180
      • Galderma Research Site
    • Boynton Beach, Florida, United States, 33437
      • Galderma Research Site
    • Coral Gables, Florida, United States, 33146
      • Galderma Research Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • Galderma Research Site
  • New York
    • New York, New York, United States, 10021
      • Galderma Research Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Galderma Research Site
    • Wilmington, North Carolina, United States, 28405
      • Galderma Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Galderma Research 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	Measure Description	Time Frame
Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS)	Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% confidence interval (CI) were calculated using the normal approximation (Wald) method.	Baseline, Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50%	Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by blinded evaluator at Month 3, compared with a reference standard responder rate of 50%.	Baseline, Month 3
Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator	Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by a blinded evaluator at Months 6, 9 and 12 are reported here.	Months 6, 9 and 12

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 (Actual): December 11, 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): May 22, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

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