Upper Facial Remodeling With Perlane-L and Dysport (DPL-2010)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||May 2012|
Dysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|