Upper Facial Remodeling With Perlane-L and Dysport

NCT01354743 | Completed Phase 4

• 1 other identifier: DysportPerlaneL-2010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild to Moderate Temporal Atrophy; Moderate to Severe Glabellar Rhytids; Moderate to Severe Periorbital Rhytids

Keywords

atrophy; rhytids; glabellar; periorbital

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Measure of rejuvenation in glabella and/or periorbital regions

  9 months

Study Arms (1)

Dysport

OTHER

Dysport injections into the glabella and orbicularis oculi muscles with dose based on muscle mass

Drug: Dysport; Device: Perlane L

Interventions

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 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.

Dysport

Perlane L DEVICE

The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area.

Dysport

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• hormonal contraceptives† (oral, patch, injection, implant);
• male condom with intra-vaginal spermicide or diaphragm or cervical cap with spermicide;
• vaginal contraceptive ring;
• intrauterine device;

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beer, Kenneth R., M.D., PA: lead
• Medicis Pharmaceutical Corporation: collaborator

Study Sites (1)

Kenneth R. Beer, M.D., PA

West Palm Beach, Florida, 33401, United States

Location

MeSH Terms

Conditions

Atrophy

Interventions

abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth Beer M.D.

  Kenneth Beer, M.D., PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 17, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

US (1)