Upper Facial Remodeling With Perlane-L and Dysport

PHASE4CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

December 31, 2011

Study Completion Date

May 31, 2012

Conditions
Mild to Moderate Temporal AtrophyModerate to Severe Glabellar RhytidsModerate to Severe Periorbital Rhytids
Interventions
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.

Trial Locations (1)

33401

Kenneth R. Beer, M.D., PA, West Palm Beach

Sponsors
All Listed Sponsors
collaborator

Medicis Pharmaceutical Corporation

INDUSTRY

lead

Beer, Kenneth R., M.D., PA

INDIV