Study Results
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View full resultsBasic Information
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COMPLETED
NA
333 participants
INTERVENTIONAL
2019-11-11
2022-04-06
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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Restylane-L Treatment
Restylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months.
Restylane-L®
Intradermal injection.
No Treatment Control
No treatment control with optional treatment at 12 months.
No interventions assigned to this group
Interventions
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Restylane-L®
Intradermal injection.
Eligibility Criteria
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Inclusion Criteria
* Males or non-pregnant, non-breastfeeding females, over the age of 21.
* Intent to undergo correction of both orbital hollows.
Exclusion Criteria
* Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
* Previous deep and/or superficial facial dermal therapies.
* Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.
22 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Locations
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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
Westport, Connecticut, United States
Galderma Research Site
Boynton Beach, Florida, United States
Galderma Research Site
Coral Gables, Florida, United States
Galderma Research Site
West Palm Beach, Florida, United States
Galderma Research Site
Chicago, Illinois, United States
Galderma Research Site
Chestnut Hill, Massachusetts, United States
Galderma Research Site
New York, New York, United States
Galderma Research Site
New York, New York, United States
Galderma Research Site
Rochester, New York, United States
Galderma Research Site
Wilmington, North Carolina, United States
Galderma Research Site
Nashville, Tennessee, United States
Galderma Research Site
Spring, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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43USTT1904
Identifier Type: -
Identifier Source: org_study_id
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