Study to Evaluate the Safety of Retreatment With Restylane® Lyft With Lidocaine for Augmentation of the Chin Region
Part of paid clinical trials in Westport, Connecticut.
- Sponsor
- Galderma R&D
- Study ID
- NCT07566286
- Status
- Not Yet Recruiting
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Conditions
- Chin Augmentation
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Restylane Lyft with Lidocaine — DEVICESterile gel of hyaluronic acid.
Study Details
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.
Key Dates
- Start date
- Jun 1, 2026
- Status verified
- Apr 2026
- Primary completion
- Nov 1, 2027
- Completion
- Feb 28, 2028
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dermal Filler for Indication: 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.
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) ]
Central Contacts
- Clinical Project Manager817-961-5000
Locations (8)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Galderma Investigational Site # 8680 | Westport | Connecticut | 06880 | Galderma Project Manager |
| Galderma Investigational Site # 8774 | Boynton Beach | Florida | 33437 | Galderma Project Manager |
| Galderma Investigational Site # 7030 | Coral Gables | Florida | 33134 | Galderma Project Manager |
| Galderma Investigational Site # 8682 | Coral Gables | Florida | 33134 | Galderma Project Manager |
| Galderma Investigational Site # 7042 | Atlanta | Georgia | 30331 | Galderma Project Manager |
| Galderma Investigational Site # 7043 | Bethesda | Maryland | 20852 | Galderma Project Manager |
| Galderma Investigational Site # 7118 | Nashville | Tennessee | 37203 | - |
| Galderma Investigational Site # 8662 | Spring | Texas | 77388 | Galderma Project Manager |