NCT01354743

Upper Facial Remodeling With Perlane-L and Dysport

Upper Facial Remodeling With Perlane-L and Dysport.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Beer, Kenneth R., M.D., PA · Individual
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to provide data to support combination treatment of the upper face with Perlane-L® and Dysport™. This study will assess the outcome of upper face rejuvenation in the temporal fossa; outcome of glabella and/or periorbital regions will also be assessed as a secondary endpoint.

Conditions

• Mild to Moderate Temporal Atrophy
• Moderate to Severe Glabellar Rhytids
• Moderate to Severe Periorbital Rhytids

Interventions

Type	Name	Description
DRUG	Dysport	Patients entering will be based on gender and assessment of procerus and corrugator muscle mass. Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large) by assessment of the procerus/corrugator muscles. Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ Female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region Subjects will be treated with Dysport™ 20 or 30 units bilaterally to crow's feet. Subjects will be treated at baseline and if maximum amount of product has not been used at 1 month follow up subject will receive a touch up. No further treatment will be done for the remaining study visits.
DEVICE	Perlane L	The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-12-01
• Completion: 2012-05-01
• First posted: 2011-05-17
• Last updated: 2013-09-26

Locations

1 site across 1 country: United States