Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

Galderma R&D60 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lip Augmentation and Correction of Perioral Rhytids

Interventions

Restylane Silk with LidocaineDEVICE

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

United States, California

Beverly Hills, California, United States

United States, California

San Diego, California, United States

United States, Florida

Miami, Florida, United States

United States, Georgia

Roswell, Georgia, United States

Outcomes

Primary Outcomes

Number of Participants With Adverse Events With the Use of Restylane Silk With Lidocaine

Time frame: 12 weeks

Data from ClinicalTrials.gov

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