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

NCT05691972 | Completed Results FDA Device

• 1 other identifier: 43USTH2201
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 15

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.

Conditions

Temporal Hollowing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to 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

  Months 6, 9 and 12

Study Arms (2)

Treatment

EXPERIMENTAL

Device: Restylane Contour

Control

NO INTERVENTION

Interventions

Restylane Contour DEVICE

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

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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

Sponsors & Collaborators

• Galderma R&D: lead

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

Results Point of Contact

• Title: Galderma Clinical Project Manager
• Organization: Galderma

Clinical.Studies@galderma.com

+1 817-961-5000

Study Officials

• Study Director

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

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: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)