Upper Facial Remodeling With Perlane-L and Dysport (DPL-2010)
|ClinicalTrials.gov Identifier: NCT01354743|
Recruitment Status : Completed
First Posted : May 17, 2011
Last Update Posted : September 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Mild to Moderate Temporal Atrophy Moderate to Severe Glabellar Rhytids Moderate to Severe Periorbital Rhytids||Drug: Dysport Device: Perlane L||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Upper Facial Remodeling With Perlane-L and Dysport.|
|Study Start Date :||December 2010|
|Primary Completion Date :||December 2011|
|Study Completion Date :||May 2012|
Dysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass
Device: Perlane L
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.
The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area.
- Upper face rejuvenation in the temporal fossa [ Time Frame: 9months ]Subjects are assessed from a Four Point Temporal Atropy scale at baseline(must present with a 1 or 2 score).Subject will be assessed at 1 month with additonal treatment if needed and return at month 3,6, and 9 months and be assessed with the Four Point Atrophy Scale.
- Measure of rejuvenation in glabella and/or periorbital regions [ Time Frame: 9 months ]
Mild to moderate glabella rhytids and Periocular rhytids by a measurement of 3 or more upon evaluation using the Rao-Goldman 5-point Facial Wrinkle Scale.
Subject will be assessed at 1 month with additonal treatment if needed and return at month 3,6, and 9 months and be assessed with Rao-Goldman 5-point Facial Wrinkle Scale.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354743
|United States, Florida|
|Kenneth R. Beer, M.D., PA|
|West Palm Beach, Florida, United States, 33401|
|Principal Investigator:||Kenneth Beer M.D.||Kenneth Beer, M.D., PA|