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

N/ACompletedNCT05691972

Galderma R&D225 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

225

Conditions

Temporal Hollowing

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)

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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

Locations (15)

Galderma Research Site

Phoenix, Arizona, United States

Galderma Research Site

Encino, California, United States

Galderma Research Site

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Month 3

Secondary Outcomes

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%.

Time frame: 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.

Data from ClinicalTrials.gov

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