Upper Facial Remodeling With Perlane-L and Dysport (DPL-2010)
This study has been completed.
Medicis Pharmaceutical Corporation
Information provided by (Responsible Party):
Beer, Kenneth R., M.D., PA
First received: May 11, 2011
Last updated: September 24, 2013
Last verified: September 2013
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.
Mild to Moderate Temporal Atrophy
Moderate to Severe Glabellar Rhytids
Moderate to Severe Periorbital Rhytids
Device: Perlane L
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Upper Facial Remodeling With Perlane-L and Dysport.
Primary Outcome Measures:
- Upper face rejuvenation in the temporal fossa [ Time Frame: 9months ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Measure of rejuvenation in glabella and/or periorbital regions [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||40 Years to 75 Years (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Outpatient,male or female subjects of any race, 40-75 years of age.
- Mild to Moderate temoral atrophy of (1 or 2 on Four Point Temporal Atrophy Scale)
- One of the following:
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.
- Subjects will be enrolled if previous history of facial cold sores, but will be medicated to avoid any recurrence.
- able to understand the requirements of the study and sign a Institutional Review Board Informed Consent/HIPPA Authorization forms and receive a copy.
- Subjects of childbearing potential must have a negative urine pregnancy test result at baseline and practice a reliable method of contraception throughout the study: A female is considered of childbearing potential unless she is post menopausal for >12 months prior to study drug administration.
- without a uterus and/or both ovaries; or
- surgically sterile (e.g., tubal ligation) for >6 months prior to study drug administration.
The following methods of contraception, if properly used, are generally considered reliable for females of childbearing potential who may participate in the study:
- Previous injection of botulinum toxin of any serotype within 6 months, Previous injection of semi-permanent fillers in the upper face (i.e. glabella, periorbital, temporal areas) within the last 12 months. Previous injection of permanent fillers in the upper face (i.e. glabella, periorbital, temporal areas) are excluded.
- Subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.
- Subjects planning a facial cosmetic procedure during the study period or with prior cosmetic procedures (i.e., surgery) or visible scars that may affect the evaluation of response.
- Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring,thick sebaceous skin, or an inability to substantially lessen upper facial rhytids even by physically spreading them apart.
- Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.).
- Laser resurfacing, or soft tissue augmentation in the periocular area in the 12 months preceding Visit 1.
- Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function.
- Current use of aminoglycoside antibiotics, curare-like agents, or agents that might interfere with neuromuscular (skeletal) function.
- Profound atrophy/excessive weakness of muscles in target areas of injection.
- History of facial nerve palsy.
- Any patients with known autoimmune disease or compromised immune systems ie HIV, AIDS or current chemotherapy.
- Infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery).
- Allergy or sensitivity to any component of Dysport™ and/or Perlane-L®.
- Evidence of recent alcohol or drug abuse.
- Medical and/or psychiatric problems that is severe enough to interfere with the study results (Investigator opinion).
- History of poor cooperation, non-compliance with medical treatment, or unreliability.
- Exposure to an investigational drug study within 30 days of the Baseline Visit.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354743
|Kenneth R. Beer, M.D., PA
|West Palm Beach, Florida, United States, 33401 |
Beer, Kenneth R., M.D., PA
Medicis Pharmaceutical Corporation
||Kenneth Beer M.D.
||Kenneth Beer, M.D., PA
||Beer, Kenneth R., M.D., PA
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 11, 2011
||September 24, 2013
||United States: Institutional Review Board
Keywords provided by Beer, Kenneth R., M.D., PA:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 26, 2016
Pathological Conditions, Anatomical
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Peripheral Nervous System Agents