N/A N=60 Treatment

Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

Lip Augmentation and Correction of Perioral Rhytids

Bottom Line

View on ClinicalTrials.gov: NCT02703948 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2018

Primary outcome: Primary: Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine — 11 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Restylane Silk with Lidocaine (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine	11	—

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 .

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.

View full record on ClinicalTrials.gov →

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.