N/A
Completed N=180
Safety/Efficacy Study of Restylane® in Lip Augmentation
Lip Augmentation
Source: ClinicalTrials.gov NCT00935272 ↗
Enrolled (actual)
180
Serious AEs
1.8%
Results posted
Jan 2012
Primary outcomePrimary: Percentage of Participants With Response — 92.6; 28.9 Percentage of Participants
Summary
To determine the safety and effectiveness of Restylane® when used for lip augmentation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Response |
92.6; 28.9 | — |
| SECONDARY Percentage of Participants With a Response |
90.1; 36.8; 84.2; 35.9; 75.0; 33.3 | — |
Eligibility Criteria
Inclusion Criteria
- Must meet established lip fullness criteria
Exclusion Criteria
- Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations
Data sourced from ClinicalTrials.gov (NCT00935272). 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.