Clinical trial NCT01401803: Brow Lifting With Dysport
Official title: Brow Lifting With Dysport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brow Ptosis
Lid Ptosis
Keywords: periorbital
glabella
ptosis
eyelid
brow
Lead sponsor: Beer, Kenneth R., M.D., PA
Sponsor class: INDIV
Collaborators: name: Medicis Pharmaceutical Corporation
First posted: 2011-07-25
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide data to assess Dysport™ injections as a treatment therapy for brow ptosis. This study will assess the outcome of brow lifting with use of Dysport.

Detailed description: One of the most common reasons that patients present to both dermatologists and plastic surgeons is for brow and lid ptosis. Although some patients that present for these entities require surgery, most will decline to have surgical intervention. Alternative treatments include brow lifting with botulinum toxins.

Brow lifting with botulinum toxins may be performed by injecting the muscles responsible for brow and lid depression. These muscles include: the corrugators, procerus, medical aspect of the frontalis and the depressor component of the orbicularis oculi muscles. By relaxing these muscles, the brow elevators may be able to lift the brow and help both brow and lid ptosis. This trial is unique as it utilizes Dysport to treat an entire anatomic muscle group (the brow depressors) rather than injecting isolated muscles._

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects of any race, 25-75 years of age
* Mild to Moderate brow ptosis (2 or 3 on a 5-point Brow Positioning Grading Scale)
* Subject has signed the IRB-approved Informed Consent Form and the Authorization for Use and Release of Health and Research Study Information (HIPAA) form prior to any study-related procedures being performed
* Subject is able to follow study instructions and likely to complete all required visits, as assessed by the Treating Investigator
* Subject has had a urine pregnancy test evaluated as negative\* within 7 days prior to planned study treatment, has used contraception for at least a month prior to planned study treatment, and agrees to use contraception for the duration of the study
* 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:

* postmenopausal 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;
* 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.

    * Vasectomized \>3 months or with a 0 sperm count; \* Female subjects of childbearing potential who are not sexually active are not required to practice a reliable method of contraception. They may be enrolled at the Investigator's discretion provided that they are counseled to remain sexually inactive for the duration of the study and understand the possible risks involved in getting pregnant during the study.

Exclusion Criteria:

* 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 12months 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™
* 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

Primary outcomes:
measure: Correction of brow ptosis with dysport injection
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Kenneth R. Beer, M.D., PA
state: Florida
Study officials:
affiliation: Kenneth Beer, M.D.,PA
name: Kenneth Beer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flynn TC, Carruthers JA, Carruthers JA, Clark RE 2nd. Botulinum A toxin (BOTOX) in the lower eyelid: dose-finding study. Dermatol Surg. 2003 Sep;29(9):943-50; discussion 950-1. doi: 10.1046/j.1524-4725.2003.29257.x.
citation: Carruthers JA, Lowe NJ, Menter MA, Gibson J, Nordquist M, Mordaunt J, Walker P, Eadie N; BOTOX Glabellar Lines I Study Group. A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines. J Am Acad Dermatol. 2002 Jun;46(6):840-9. doi: 10.1067/mjd.2002.121356.
citation: Carruthers A, Carruthers J, Said S. Dose-ranging study of botulinum toxin type A in the treatment of glabellar rhytids in females. Dermatol Surg. 2005 Apr;31(4):414-22; discussion 422. doi: 10.1111/j.1524-4725.2005.31107.