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Clinical Trials/NCT05691972
NCT05691972CompletedNot Applicable

A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

Galderma R&D16 sites in 1 country225 target enrollmentStarted: March 14, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
225
Locations
16
Primary Endpoint
Responder rate based on the Blinded Evaluators' live assessment of the GTVDS
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
22 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Treatment

Experimental

Intervention: Restylane Contour (Device)

Control

No Intervention

Outcomes

Primary Outcomes

Responder rate based on the Blinded Evaluators' live assessment of the GTVDS

Time Frame: Baseline to 3 months

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (16)

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