NCT05987163

Brief 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).

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
2 countries

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

April 12, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 2, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

April 4, 2023

Last Update Submit

June 26, 2025

Conditions

Skin Manifestations

Outcome Measures

Primary Outcomes (1)

  • To demonstrate non-inferiority of GP0116 versus a comparator control

    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).

    At 3 months after Baseline

Study Arms (2)

GP0116

EXPERIMENTAL
Device: GP0116

FDA Approved Device

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

Interventions

GP0116DEVICE

GP0116 is an injectable, sterile, transparent product.

GP0116
Active Comparator: FDA approved dermal filler device (RHA 3)DEVICE

FDA approved dermal filler device (RHA 3)

FDA Approved Device

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and non-pregnant, non-breastfeeding women aged 22 years or older.
  • 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.

You may not qualify if:

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Galderma Investigational Site (Site#8074)

Santa Monica, California, 90404, United States

Location

Galderma Investigational Site (Site#8478)

Vista, California, 92083, United States

Location

Galderma Investigational Site (Site#8680)

Westport, Connecticut, 06880, United States

Location

Galderma Investigational Site (Site#8479)

Bradenton, Florida, 34209, United States

Location

Galderma Investigational Site (Site#7030)

Coral Gables, Florida, 33134, United States

Location

Galderma Investigational Site (Site#8284)

Coral Gables, Florida, 33146, United States

Location

Galderma Investigational Site (Site#8126)

West Palm Beach, Florida, 33401, United States

Location

Galderma Investigational Site (Site#7042)

Atlanta, Georgia, 30331, United States

Location

Galderma Investigational Site (Site#8580)

New Orleans, Louisiana, 70130, United States

Location

Galderma Investigational Site (Site#8481)

Chestnut Hill, Massachusetts, 02467, United States

Location

Galderma Investigational Site (Site#8631)

Birmingham, Michigan, 48009, United States

Location

Galderma Investigational Site (Site#8658)

New York, New York, 10021, United States

Location

Galderma Investigational Site (Site#8482)

Chapel Hill, North Carolina, 27517, United States

Location

Galderma Investigational Site (Site#8648)

Wilmington, North Carolina, 28405, United States

Location

Galderma Investigational Site (Site#8783)

Cincinnati, Ohio, 45236, United States

Location

Galderma Investigational Site (Site#8496)

Nashville, Tennessee, 37203, United States

Location

Galderma Investigational Site (Site#8662)

Spring, Texas, 77388, United States

Location

Galderma Investigational Site (Site#7047)

Arlington, Virginia, 22209, United States

Location

Galderma Investigational Site (Site#8784)

San Juan, 00917, Puerto Rico

Location

MeSH Terms

Conditions

Skin Manifestations

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2023

First Posted

August 14, 2023

Study Start

April 12, 2023

Primary Completion

October 29, 2024

Study Completion

March 31, 2026

Last Updated

July 2, 2025

Record last verified: 2025-06

Locations

US(18)PR(1)