Chin AugmentationNCT07566286
Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region
A study testing Restylane Lyft with Lidocaine in people with Chin Augmentation, run by Galderma R&D at 8 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chin Augmentation
- What is being tested?
- Restylane Lyft with Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Jun 2026to 28 Feb 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
- Intent to receive treatment for augmentation and correction of retrusion in the chin region.
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from subnasale.
- Any previous aesthetic procedures or implants.
- Presence of any disease or lesions near or on the area to be treated.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Galderma Investigational Site # 7042
Atlanta, Georgia, 30331
Galderma Project Manager
- Not yet recruiting
Galderma Investigational Site # 7043
Bethesda, Maryland, 20852
Galderma Project Manager
- Recruiting
Galderma Investigational Site # 8774
Boynton Beach, Florida, 33437
Galderma Project Manager
- Recruiting
Galderma Investigational Site # 7030
Coral Gables, Florida, 33134
Galderma Project Manager
- Recruiting
Galderma Investigational Site # 8682
Coral Gables, Florida, 33134
Galderma Project Manager
- Recruiting
Galderma Investigational Site # 7118
Nashville, Tennessee, 37203
Galderma Project Manager
- Recruiting
Galderma Investigational Site # 8662
Spring, Texas, 77388
Galderma Project Manager
- Recruiting
Galderma Investigational Site # 8680
Westport, Connecticut, 06880
Galderma Project Manager
About this study
Official title: A Prospective, Multicenter Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.
- Conditions
- Chin Augmentation
- Being tested
- Restylane Lyft with Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane Lyft with LidocaineDevice
Sterile gel of hyaluronic acid.
| Study group | Role | What they receive |
|---|---|---|
| Dermal Filler for Indication: Restylane Lyft with Lidocaine | Experimental | Participants will receive initial treatment with Restylane Lyft with Lidocaine in the chin region at Baseline with an optional touch-up treatment at 1 month after initial treatment and an optional retreatment 12 months after the last treatment. Receives: Device: Restylane Lyft with Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational product (IP). TEAEs that are related to the device and/or injection procedure after the Month 12 optional retreatment will be reported.
Measured: From Month 12 up to 3 months after optional retreatment (i.e. Month 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start3 Jun 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chin AugmentationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT07566286
- Sponsor's protocol ID
- 05DF2506
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region to Improve the Chin Profile
- ClinicalTrials.gov ID
- NCT07566286
- Acronym / sponsor ID
- 05DF2506
- Conditions
- Chin Augmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 5 May 2026 (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.
The primary objective of this study is to evaluate the safety of Restylane Lyft with Lidocaine for augmentation of the chin region 3 months after retreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dermal Filler for Indication: Restylane Lyft with Lidocaine | Experimental | Device: Restylane Lyft with LidocaineParticipants will receive initial treatment with Restylane Lyft with Lidocaine in the chin region at Baseline with an optional touch-up treatment at 1 month after initial treatment and an optional retreatment 12 months after the last treatment. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
- Intent to receive treatment for augmentation and correction of retrusion in the chin region.
Key exclusion criteria (6 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
- Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
- Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from subnasale.
- Any previous aesthetic procedures or implants.
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 |
|---|---|---|
| Restylane Lyft with LidocaineSterile gel of hyaluronic acid. | Device | Dermal Filler for Indication: Restylane Lyft with Lidocaine |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment
Time frame: From Month 12 up to 3 months after optional retreatment (i.e. Month 15)
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users or other persons, in the context of a clinical investigation, whether or not related to the investigational product (IP). TEAEs that are related to the device and/or injection procedure after the Month 12 optional retreatment will be reported.
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 14 Aug 2026.
- Individual participant dataSharing planned: No
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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Lyft with Lidocaine in people with Chin Augmentation, run by Galderma R&D at 8 sites in United States.
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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
Contact Clinical Project Manager (817-961-5000 ext. +1, clinical.studies@galderma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Related to Device And/Or Injection Procedure After the Month 12 Optional Retreatment (time frame: From Month 12 up to 3 months after optional retreatment (i.e. Month 15)). 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 14 Aug 2026.