N/A
Completed N=59
Study to Evaluate Satisfaction After Treatment With Kysse
Lip Augmentation
Source: ClinicalTrials.gov NCT03967444 ↗
Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Assess Treatment With Restylane Kysse Using GAIS — 18; 38 Participants
Summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Treatment With Restylane Kysse Using GAIS |
18; 38 | — |
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
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. Informational only — not medical advice.