Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study to Evaluate the Safety and Effectiveness of GP0116
NCT05987163 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
Conditions Studied
Interventions
- DEVICE GP0116
- DEVICE Active Comparator: FDA approved dermal filler device (RHA 3)
Study Locations (19)
Florida
- Galderma Investigational Site (Site#8479) — Bradenton
- Galderma Investigational Site (Site#7030) — Coral Gables
- Galderma Investigational Site (Site#8284) — Coral Gables
- Galderma Investigational Site (Site#8126) — West Palm Beach
California
- Galderma Investigational Site (Site#8074) — Santa Monica
- Galderma Investigational Site (Site#8478) — Vista
North Carolina
- Galderma Investigational Site (Site#8482) — Chapel Hill
- Galderma Investigational Site (Site#8648) — Wilmington
Connecticut
- Galderma Investigational Site (Site#8680) — Westport
Georgia
- Galderma Investigational Site (Site#7042) — Atlanta
Louisiana
- Galderma Investigational Site (Site#8580) — New Orleans
Massachusetts
- Galderma Investigational Site (Site#8481) — Chestnut Hill
Michigan
- Galderma Investigational Site (Site#8631) — Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2023-04-12 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05987163
The ClinicalTrials.gov registry entry for NCT05987163 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galderma R&D, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Skin Manifestations appearing as the primary indexed condition, and to 2 interventions — of which GP0116 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05987163 reports 19 study locations spanning 14 distinct geographic areas — top geographies include Florida, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05987163 about?
NCT05987163 is a clinical study titled "Study to Evaluate the Safety and Effectiveness of GP0116". This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
What is the current status of trial NCT05987163?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 186 participants. The study started on 2023-04-12. Estimated completion is 2026-03-31.
What conditions does trial NCT05987163 study?
This clinical trial studies the following conditions: Skin Manifestations. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05987163?
The interventions under investigation include: GP0116 (DEVICE), Active Comparator: FDA approved dermal filler device (RHA 3) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05987163?
This trial is sponsored by Galderma R&D, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05987163 being conducted?
This trial has 19 study locations across California, Connecticut, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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