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

Galderma

Status: Completed

Conditions: Temporal Hollowing

Treatments: Device: Restylane Contour

Study type: Interventional

Funder types: Industry

Identifiers

NCT05691972

43USTH2201

Details and patient eligibility

About

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.

Enrollment: 225 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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225 participants in 2 patient groups

Treatment

Experimental group

Treatment:

Device: Restylane Contour

Control

No Intervention group