N/A
Completed N=60
Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation
Lip Augmentation and Correction of Perioral Rhytids
Source: ClinicalTrials.gov NCT02703948 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine — 11 Participants
Summary
This is a multi-center, open-label, single-arm study to assess the safety of an injection technique with Restylane Silk in lip augmentation and correction of perioral rhytids .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine |
11 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects willing to comply with the requirements of the study and providing written informed consent including release of copyright of photography images.
- Males or females, 22 years of age or older
- Subjects seeking augmentation therapy for the lips.
Exclusion Criteria
- History of allergy or hypersensitivity to injectable HA gel or to gram positive bacterial proteins.
- History of allergy or hypersensitivity to lidocaine, other amide type anesthetics, or topical anesthetics or nerve blocking agents
- Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
Data sourced from ClinicalTrials.gov (NCT02703948). 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.