Skin ManifestationsNLFNCT05987163
Study to Evaluate the Safety and Effectiveness of GP0116
A study testing GP0116 and Active Comparator: FDA approved dermal filler device (RHA 3) in people with Skin Manifestations, run by Galderma R&D at 19 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Skin Manifestations
- What is being tested?
- GP0116 and Active Comparator: FDA approved dermal filler device (RHA 3)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 12 Apr 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Galderma Investigational Site (Site#7047)
Arlington, Virginia, 22209
Galderma Investigational Site (Site#7042)
Atlanta, Georgia, 30331
Galderma Investigational Site (Site#8631)
Birmingham, Michigan, 48009
Galderma Investigational Site (Site#8479)
Bradenton, Florida, 34209
Galderma Investigational Site (Site#8482)
Chapel Hill, North Carolina, 27517
Galderma Investigational Site (Site#8481)
Chestnut Hill, Massachusetts, 02467
Galderma Investigational Site (Site#8783)
Cincinnati, Ohio, 45236
Galderma Investigational Site (Site#7030)
Coral Gables, Florida, 33134
Galderma Investigational Site (Site#8284)
Coral Gables, Florida, 33146
Galderma Investigational Site (Site#8496)
Nashville, Tennessee, 37203
Galderma Investigational Site (Site#8580)
New Orleans, Louisiana, 70130
Galderma Investigational Site (Site#8658)
New York, New York, 10021
Galderma Investigational Site (Site#8074)
Santa Monica, California, 90404
Galderma Investigational Site (Site#8662)
Spring, Texas, 77388
Galderma Investigational Site (Site#8478)
Vista, California, 92083
Galderma Investigational Site (Site#8126)
West Palm Beach, Florida, 33401
Galderma Investigational Site (Site#8680)
Westport, Connecticut, 06880
Galderma Investigational Site (Site#8648)
Wilmington, North Carolina, 28405
Puerto Rico1 site
Galderma Investigational Site (Site#8784)
San Juan, 00917
About this study
Official title: 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.
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
- Being tested
- GP0116, Active Comparator: FDA approved dermal filler device (RHA 3)
- Medical subject headings
- Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP0116Device
GP0116 is an injectable, sterile, transparent product.
Active Comparator: FDA approved dermal filler device (RHA 3)Device
FDA approved dermal filler device (RHA 3)
| Study group | Role | What they receive |
|---|---|---|
| GP0116 | Experimental | Not described Receives: Device: GP0116 |
| FDA Approved Device | Active comparator | Not described Receives: Device: Active Comparator: FDA approved dermal filler device (RHA 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 3 months after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start12 Apr 2023
- Primary completion29 Oct 2024
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ManifestationsStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987163
- Sponsor's protocol ID
- 43N3US2204
- Acronym
- NLF
- Status last verified
- Jun 2025
- First submitted
- 4 Apr 2023
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05987163
- Acronym / sponsor ID
- NLF / 43N3US2204
- Conditions
- Skin Manifestations
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP0116 | Experimental | Device: GP0116 |
| FDA Approved Device | Active comparator | Device: Active Comparator: FDA approved dermal filler device (RHA 3) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP0116GP0116 is an injectable, sterile, transparent product. | Device | GP0116 |
| Active Comparator: FDA approved dermal filler device (RHA 3)FDA approved dermal filler device (RHA 3) | Device | FDA Approved Device |
Primary outcome
To demonstrate non-inferiority of GP0116 versus a comparator control
Time frame: At 3 months after Baseline
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP0116 and Active Comparator: FDA approved dermal filler device (RHA 3) in people with Skin Manifestations, run by Galderma R&D at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate non-inferiority of GP0116 versus a comparator control (time frame: At 3 months after Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.