ClinicalTrials.gg
RecruitingNCT07566286Updated Aug 14, 2026

Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region

An interventional study of Restylane Lyft with Lidocaine in Chin Augmentation, sponsored by Galderma R&D. Recruiting at 8 sites in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Galderma R&D (part of Galderma Group AG) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chin Augmentation
03

In context

Lead sponsor

Galderma R&D is the lead sponsor of 284 studies on the registry; 11 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
  2. Intent to receive treatment for augmentation and correction of retrusion in the chin region.

Exclusion criteria

Exclusion Criteria:

  1. Known/previous allergy or to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
  2. Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics.
  3. Previous or present multiple allergies or severe allergies, such as manifested by anaphylaxis or angioedema, or family history of these conditions.
  4. Previous facial surgery (including facial aesthetic surgery and liposuction), below the level of the horizontal line from subnasale.
  5. Any previous aesthetic procedures or implants.
  6. Presence of any disease or lesions near or on the area to be treated.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Dermal Filler for Indication: Restylane Lyft with Lidocaine

    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.

    Device: Restylane Lyft with Lidocaine

Interventions

  • DeviceRestylane Lyft with Lidocaine

    Sterile gel of hyaluronic acid.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Month 12 up to 3 months after optional retreatment (i.e. Month 15)

07

Study locations

7 of 8 sites recruiting
  • Galderma Investigational Site # 8680
    Westport, Connecticut 06880, United States
    Recruiting
    • Galderma Project Manager · Contact
  • Galderma Investigational Site # 8774
    Boynton Beach, Florida 33437, United States
    Recruiting
    • Galderma Project Manager · Contact
  • Galderma Investigational Site # 7030
    Coral Gables, Florida 33134, United States
    Recruiting
    • Galderma Project Manager · Contact
  • Galderma Investigational Site # 8682
    Coral Gables, Florida 33134, United States
    Recruiting
    • Galderma Project Manager · Contact
  • Galderma Investigational Site # 7042
    Atlanta, Georgia 30331, United States
    Recruiting
    • Galderma Project Manager · Contact
  • Galderma Investigational Site # 7043
    Bethesda, Maryland 20852, United States
    Not yet recruiting
    • Galderma Project Manager · Contact
  • Galderma Investigational Site # 7118
    Nashville, Tennessee 37203, United States
    Recruiting
    • Galderma Project Manager · Contact
  • Galderma Investigational Site # 8662
    Spring, Texas 77388, United States
    Recruiting
    • Galderma Project Manager · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for Nov 2027, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2026
First posted
May 5, 2026
StartActual
Jun 3, 2026
Primary completionEst.
Nov 1, 2027
CompletionEst.
Feb 28, 2028
Last update
Aug 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07566286
Lead sponsor
Galderma R&D
Responsible party
Sponsor
First posted
May 5, 2026
Start date
Jun 3, 2026
Primary completion
Nov 1, 2027 (estimated)
Completion
Feb 28, 2028 (estimated)
Last update
Aug 14, 2026

Study contacts

Clinical Project Manager
Contact
clinical.studies@galderma.com
817-961-5000 ext. +1

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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