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

NCT ID: NCT05691972

Last Updated: 2025-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-14

Study Completion Date

2024-12-11

Brief Summary

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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

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Conditions

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Temporal Hollowing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

Group Type EXPERIMENTAL

Restylane Contour

Intervention Type DEVICE

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Restylane Contour

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Galderma Research Site

Phoenix, Arizona, United States

Site Status

Galderma Research Site

Encino, California, United States

Site Status

Galderma Research Site

Los Angeles, California, United States

Site Status

Galderma Research Site

Redondo Beach, California, United States

Site Status

Galderma Research Site

Solana Beach, California, United States

Site Status

Galderma Research Site

Vista, California, United States

Site Status

Galderma Research Site

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

Site Status

Galderma Research Site

Adventura, Florida, United States

Site Status

Galderma Research Site

Boynton Beach, Florida, United States

Site Status

Galderma Research Site

Coral Gables, Florida, United States

Site Status

Galderma Research Site

New Orleans, Louisiana, United States

Site Status

Galderma Research Site

New York, New York, United States

Site Status

Galderma Research Site

Chapel Hill, North Carolina, United States

Site Status

Galderma Research Site

Wilmington, North Carolina, United States

Site Status

Galderma Research Site

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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43USTH2201

Identifier Type: -

Identifier Source: org_study_id

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