NCT05691972

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

January 11, 2023

Last Update Submit

February 13, 2025

Conditions

Temporal Hollowing

Outcome Measures

Primary Outcomes (1)

  • Responder rate based on the Blinded Evaluators' live assessment of the GTVDS

    Baseline to 3 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

Treatment

EXPERIMENTAL
Device: Restylane Contour

Control

NO INTERVENTION

Interventions

Restylane ContourDEVICE

a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)

Treatment

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Galderma Research Site

Phoenix, Arizona, 85054, United States

Location

Galderma Research Site

Encino, California, 91436, United States

Location

Galderma Research Site

Los Angeles, California, 90069, United States

Location

Galderma Research Site

Redondo Beach, California, 90277, United States

Location

Galderma Research Site

Solana Beach, California, 92075, United States

Location

Galderma Research Site

Vista, California, 92083, United States

Location

Galderma Research Site

Washington D.C., District of Columbia, 20037, United States

Location

Galderma Research Site

Adventura, Florida, 33180, United States

Location

Galderma Research Site

Boynton Beach, Florida, 33437, United States

Location

Galderma Research Site

Coral Gables, Florida, 33146, United States

Location

Galderma Research Site

New Orleans, Louisiana, 70115, United States

Location

Galderma Research Site

New York, New York, 10021, United States

Location

Galderma Research Site

Chapel Hill, North Carolina, 27517, United States

Location

Galderma Research Site

Wilmington, North Carolina, 28405, United States

Location

Galderma Research Site

Nashville, Tennessee, 37203, United States

Location

Study Officials

  • Study Director

    Galderma R&D

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

March 14, 2023

Primary Completion

October 26, 2023

Study Completion

December 11, 2024

Last Updated

February 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

US(15)