Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05987163 · ClinicalTrials.gov registry record · NA
Study to Evaluate the Safety and Effectiveness of GP0116
A NA study of Skin Manifestations, sponsored by Galderma R&D.
- Active
- Registry status
- NA
- Development phase
- 186
- Enrollment target
- 19
- Study locations
NCT05987163: Active NA study of Skin Manifestations, sponsored by Galderma R&D.
NCT05987163 is a NA study of Skin Manifestations that is active but no longer recruiting, run by Galderma R&D. The registered enrollment target is 186 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). The trial reports 19 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05987163, a NA study of Skin Manifestations, is active but no longer recruiting, sponsored by Galderma R&D.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 186 participants
- Enrollment target
- 19
- Study locations
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).
Primary Outcome
To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS).
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 |
What the registry record for NCT05987163 still lists
NCT05987163 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
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.
NCT05987163 lists 19 locations in 14 states (Florida, California, North Carolina).
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.
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).
Who is sponsoring clinical trial NCT05987163?
This trial is sponsored by Galderma R&D, which has 158 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Skin Manifestations
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05987163's enrollment target sits among peer trials
186 579th of 2000 higher than 1,421 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03567889 · 186 participants · Phase 3
Efficacy of Daromun Neoadjuvant Intratumoral Treatment in Clinical Stage IIIB/C/D Melanoma Patients
- NCT05281471 · 186 participants · Phase 3
Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
- NCT05405595 · 186 participants · Phase 1
ADG126 in Combination With Pembrolizumab in Patients With Advanced/Metastatic Solid Tumors
- NCT05762107 · 186 participants · Phase 2
A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI