N/A N=59 Treatment

Study to Evaluate Satisfaction After Treatment With Kysse

Lip Augmentation

Bottom Line

View on ClinicalTrials.gov: NCT03967444 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Assess Treatment With Restylane Kysse Using GAIS — 18; 38 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hyaluronic acid (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Assess Treatment With Restylane Kysse Using GAIS	18; 38	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Signed and dated informed consent to participate in the study
Adult women and men who intend to undergo lip 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 (NCT03967444). 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.