Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
NCT ID: NCT05691972
Last Updated: 2025-02-17
Study Results
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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COMPLETED
NA
225 participants
INTERVENTIONAL
2023-03-14
2024-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment
Restylane Contour
a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)
Control
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)
Eligibility Criteria
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Inclusion Criteria
* Intent to undergo treatment for correction of temple hollowing
Exclusion Criteria
* 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
22 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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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
Galderma Research Site
Encino, California, United States
Galderma Research Site
Los Angeles, California, United States
Galderma Research Site
Redondo Beach, California, United States
Galderma Research Site
Solana Beach, California, United States
Galderma Research Site
Vista, California, United States
Galderma Research Site
Washington D.C., District of Columbia, United States
Galderma Research Site
Adventura, Florida, United States
Galderma Research Site
Boynton Beach, Florida, United States
Galderma Research Site
Coral Gables, Florida, United States
Galderma Research Site
New Orleans, Louisiana, United States
Galderma Research Site
New York, New York, United States
Galderma Research Site
Chapel Hill, North Carolina, United States
Galderma Research Site
Wilmington, North Carolina, United States
Galderma Research Site
Nashville, Tennessee, United States
Countries
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Other Identifiers
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43USTH2201
Identifier Type: -
Identifier Source: org_study_id
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