NCT01431755

A Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride

A Randomised, Subject-blinded Study of Treatment Preference During Cheek Contouring Comparing Restylane® SubQ With and Without the Addition of Lidocaine Hydrochloride 0.3%

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained. The study products will be administered in the cheek.

Detailed description

The Restylane SubQ gel is intended to be used for facial tissue augmentation. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this split-face designed study are to evaluate the pain-relieving effect and safety of adding lidocaine hydrochloride to Restylane SubQ and to evaluate the esthetic improvement obtained with the dermal filler using the global esthetic improvement scale (GEIS).

Conditions

• Facial Tissue Augmentation

Interventions

Type	Name	Description
DEVICE	Restylane SubQ	Treatment with up to 2 ml of the product
DEVICE	Restylane SubQ Lidocaine	Treatment with up to 2 ml of the product

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-10-01
• Completion: 2012-10-01
• First posted: 2011-09-12
• Last updated: 2022-09-22
• Results posted: 2014-04-23

Locations

3 sites across 1 country: Sweden