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| Name | Class |
|---|---|
| Medicis Pharmaceutical Corporation | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dysport | Other | Dysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dysport | Drug | 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 Dysportâ„¢ Female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysportâ„¢ at 5 designated injection sites in the glabellar region Subjects will be treated with Dysportâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper face rejuvenation in the temporal fossa | 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. | 9months |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of rejuvenation in glabella and/or periorbital regions | 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. | 9 months |
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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:
hormonal contraceptives†(oral, patch, injection, implant);
male condom with intra-vaginal spermicide or diaphragm or cervical cap with spermicide;
vaginal contraceptive ring;
intrauterine device;
surgical sterilization (bilateral tubal ligation);
partner vasectomized††; or
total sexual abstinence*.
Hormonal contraceptives must be started at least 90 days prior to study drug administration, and intra-uterine contraceptive device must be placed at least 30 days prior to study drug administration.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Beer M.D. | Kenneth Beer, M.D., PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenneth R. Beer, M.D., PA | West Palm Beach | Florida | 33401 | United States |
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| ID | Term |
|---|---|
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C542869 | abobotulinumtoxinA |
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| Perlane L | Device | The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area. |
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