Kenneth R. Beer, M.D., PA
West Palm Beach, Florida, 33401, United States
NCT Number: NCT01354743
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.
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Notify Me40 year–75 year
All sexes
Interventional
Phase 4
West Palm Beach, Florida, 33401, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Periocular rhytids characterized by a measurement of 3 or more during maximum attempted muscle contraction (during maximum smiling) upon evaluation using the Rao-Goldman 5 point Facial Wrinkle Scale.
Mild to moderate glabella rhytiuds by a measurment of 3 or more upon evaluation using the Rao-Goldman 5-point Facial Wrinkle Scale.
The following methods of contraception, if properly used, are generally considered reliable for females of childbearing potential who may participate in the study:
Exclusion criteria
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.
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.
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.
Beer, Kenneth R., M.D., PA
Indiv
Upper Facial Remodeling With Perlane-L and Dysport.
Acronym: DPL-2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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