Study to Evaluate the Safety and Effectiveness of GP0116
NCT ID: NCT05987163
Last Updated: 2025-07-02
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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ACTIVE_NOT_RECRUITING
NA
186 participants
INTERVENTIONAL
2023-04-12
2026-03-31
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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GP0116
GP0116
GP0116 is an injectable, sterile, transparent product.
FDA Approved Device
Active Comparator: FDA approved dermal filler device (RHA 3)
FDA approved dermal filler device (RHA 3)
Interventions
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GP0116
GP0116 is an injectable, sterile, transparent product.
Active Comparator: FDA approved dermal filler device (RHA 3)
FDA approved dermal filler device (RHA 3)
Eligibility Criteria
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Inclusion Criteria
* WSRS grade of 3 or 4 (moderate to severe folds) on each NLF as assessed by the Blinded Evaluator. The WSRS for each NLF does not need to be equal.
* Intent to undergo treatment for correction of both left and right NLF.
Exclusion Criteria
* Known/previous allergy or hypersensitivity to local anesthetics
* Previous or present severe or multiple allergies manifested by severe reactions
* Previous facial surgery near the treatment area
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 Investigational Site (Site#8074)
Santa Monica, California, United States
Galderma Investigational Site (Site#8478)
Vista, California, United States
Galderma Investigational Site (Site#8680)
Westport, Connecticut, United States
Galderma Investigational Site (Site#8479)
Bradenton, Florida, United States
Galderma Investigational Site (Site#7030)
Coral Gables, Florida, United States
Galderma Investigational Site (Site#8284)
Coral Gables, Florida, United States
Galderma Investigational Site (Site#8126)
West Palm Beach, Florida, United States
Galderma Investigational Site (Site#7042)
Atlanta, Georgia, United States
Galderma Investigational Site (Site#8580)
New Orleans, Louisiana, United States
Galderma Investigational Site (Site#8481)
Chestnut Hill, Massachusetts, United States
Galderma Investigational Site (Site#8631)
Birmingham, Michigan, United States
Galderma Investigational Site (Site#8658)
New York, New York, United States
Galderma Investigational Site (Site#8482)
Chapel Hill, North Carolina, United States
Galderma Investigational Site (Site#8648)
Wilmington, North Carolina, United States
Galderma Investigational Site (Site#8783)
Cincinnati, Ohio, United States
Galderma Investigational Site (Site#8496)
Nashville, Tennessee, United States
Galderma Investigational Site (Site#8662)
Spring, Texas, United States
Galderma Investigational Site (Site#7047)
Arlington, Virginia, United States
Galderma Investigational Site (Site#8784)
San Juan, , Puerto Rico
Countries
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Other Identifiers
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43N3US2204
Identifier Type: -
Identifier Source: org_study_id
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