Trial Outcomes & Findings for Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation (NCT NCT03160716)

NCT ID: NCT03160716

Last Updated: 2022-08-26

Results Overview

To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 16 weeks
• Results posted on: 2022-08-26

Participant Flow

Participant milestones

Measure	Treatment Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Overall Study STARTED	60
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Overall Study Lost to Follow-up	1

Baseline Characteristics

Injection Technique Assessment of Restylane Lyft With Lidocaine for Cheek Augmentation

Baseline characteristics by cohort

Measure	Treatment n=60 Participants Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Age, Continuous	52.3 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	8 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	6 Participants n=5 Participants
Race/Ethnicity, Customized White	43 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

To assess the adverse events (incidence, intensity, and duration) of Restylane® Lyft with Lidocaine in conjunction with the use of a cannula.

Outcome measures

Measure	Treatment n=60 Participants Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Number of Participants With Treatment-Emergent Adverse Events [Safety]	5 Participants

SECONDARY outcome

Timeframe: 16 weeks

To assess effectiveness using the Global Aesthetic Improvement Scale (GAIS). Responders defined as "Improved" or better on the GAIS as assessed by the investigator and participant at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).

Outcome measures

Measure	Treatment n=43 Participants Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Number of Participants With Aesthetic Improvement	43 Participants

SECONDARY outcome

Timeframe: 16 weeks

To assess effectiveness using the 4-point Midface Volume Scale. Responder defined as at least a one point improvement from the baseline score at 2 weeks after week 16 re-treatment (visit only required for participants who received re-treatment at week 16).

Outcome measures

Measure	Treatment n=43 Participants Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Number of Participants That Responded to Treatment	43 Participants

SECONDARY outcome

Timeframe: 8 weeks

To assess subject satisfaction with the treatment using the FACE-Q. Score range 1-100. The higher total score indicate greater subject satisfaction.

Outcome measures

Measure	Treatment n=59 Participants Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Subject Satisfaction	77.3 score on a scale Standard Deviation 23.5

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment n=60 participants at risk Restylane Lyft with Lidocaine: a sterile gel of hyaluronic acid (HA)
Ear and labyrinth disorders Ear pain	1.7% 1/60 • Number of events 1 • 16 weeks
Infections and infestations Influenza	1.7% 1/60 • Number of events 1 • 16 weeks
Injury, poisoning and procedural complications Arthropod bite	1.7% 1/60 • Number of events 1 • 16 weeks
Nervous system disorders Headache	1.7% 1/60 • Number of events 1 • 16 weeks
Nervous system disorders Presyncope	1.7% 1/60 • Number of events 1 • 16 weeks

Additional Information

Reception

Q-Med AB

Phone: +46184749000

Email: reception.seupp@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place