MedTrace Logo

Study to Evaluate the Safety and Effectiveness of GP0116

NCT05987163 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-07-02

No results posted yet for this 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

  • Skin Manifestations

Interventions

DEVICE

GP0116

GP0116 is an injectable, sterile, transparent product.

DEVICE

Active Comparator: FDA approved dermal filler device (RHA 3)

FDA approved dermal filler device (RHA 3)

Sponsors & Collaborators

  • Galderma R&D

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2024-10-29
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987163 on ClinicalTrials.gov