NCT01428024

Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh

An Open, Multi-center Study Evaluating Efficacy, Safety and Injection Technique of Restylane Lip Products for Lip Enhancement and Lip Rejuvenation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the efficacy and safety of two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.

Detailed description

Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is intended to restore hydrobalance and improve skin structure of the lips (referred to as lip rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this open, multicenter study are to evaluate efficacy and safety of the products for the studied indications and to collect information on injection techniques used.

Conditions

• Injection Techniques

Interventions

Type	Name	Description
DEVICE	Restylane Lip Volume	Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
DEVICE	Restylane Lip Refresh	Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-11-01
• Completion: 2012-06-01
• First posted: 2011-09-02
• Last updated: 2022-08-26
• Results posted: 2018-10-18

Locations

3 sites across 1 country: Sweden