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

Not Applicable

Completed

• Conditions: Temporal Hollowing
• Interventions: Device: Restylane Contour

• Registration Number: NCT05691972
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Study Start: 2023-03-14
• Primary Completion: 2023-10-26
• Disposition First Posted: 2023-11-30
• Disposition First Submitted: 2024-04-30
• Study Completion: 2024-12-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Restylane Contour	-

Primary Outcome Measures

Name	Time	Method
Responder rate based on the Blinded Evaluators' live assessment of the GTVDS	Baseline to 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Galderma Research Site; 🇺🇸 Nashville, Tennessee, United States