Injection Technique Assessment of Restylane Silk With Lidocaine for Lip Augmentation

Galderma

Status: Completed

Conditions: Lip Augmentation and Correction of Perioral Rhytids

Treatments: Device: Restylane Silk with Lidocaine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02703948

43USC1505

Details and patient eligibility

About

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 .

Enrollment: 60 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Restylane Silk with Lidocaine

Other group

Treatment:

Device: Restylane Silk with Lidocaine