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Study to Evaluate the Safety and Effectiveness of GP0116

A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as Nasolabial Folds.

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987163
Acronym
NLF
Enrollment
186
Registered
2023-08-14
Start date
2023-04-12
Completion date
2026-03-31
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Manifestations

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).

Interventions

DEVICEGP0116

GP0116 is an injectable, sterile, transparent product.

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

FDA approved dermal filler device (RHA 3)

Sponsors

Galderma R&D
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
To demonstrate non-inferiority of GP0116 versus a comparator controlAt 3 months after BaselineTo 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).

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026