N/A N=60 Treatment

Study to Evaluate Satisfaction After Treatment With Restylane

Cheek Augmentation

Bottom Line

View on ClinicalTrials.gov: NCT04638816 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2024

Primary outcome: Primary: Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS — 20; 17; 9; 9 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Restylane Volyme (Device); Restylane Lyft Lidocaine (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Galderma R&D
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Assess Treatment With Restylane Volyme and Restylane Lyft Lidocaine Using GAIS	20; 17; 9; 9; 1; 3	—

Summary

Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Restylane

Eligibility Criteria

Inclusion Criteria

Signed and dated informed consent to participate in the study
Adult women who intend to undergo cheek augmentation

Exclusion Criteria

Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
Subjects with a previous implant other than HA in or near the intended treatment site
Participation in any other clinical study within three (3) months before treatment

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04638816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.