Brow Lifting With Dysport

Brow Ptosis Clinical Trial

Official title:

Brow Lifting With Dysport

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401803
• Other study ID #: BrowDysport2011
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2011
• Last updated: September 24, 2013
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2013
• Source: Beer, Kenneth R., M.D., PA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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._

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brow Ptosis
• Lid Ptosis
• Prolapse

Intervention

Drug:
• Dysport
Patients entering will be based on gender and assessment of the glabella region (including the corrugators, procerus, and medial frontalis muscles). Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large). Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ and 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. On (Day0) patients will be treated with Dysport™ 10 to 20 units bilaterally to the depressor component of the orbicularis. The dosing for patients will be based on assessment of orbicularis muscle mass. Patients will receive .05 mL to 0.1 mL (10 or 20 units) in two equally divided doses of Dysport™. Muscle mass will not be graded based upon gender for this region.

Locations

Country	Name	City	State
United States	Kenneth R. Beer, M.D., PA	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Kenneth Beer	Medicis Pharmaceutical Corporation

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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 tre — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correction of brow ptosis with dysport injection	Subjects will be assessed using 5-point brow positioning grading scale at baseline, day 14, month 1,2,4 and 6 months.	6 Months	No