For subjects who desire brow lift as a means to rejuvenate the upper face.
Conditions
Interventions
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: n/a
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Clostridium type A neurotoxin complex
CAS Number: N/A
Current Spo
Sponsors
Aalst Dermatology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects of any race, between 18 and 65 years of age. - Subjects who desire botulinum toxin type A injections for brow lift as a means to rejuvenate the upper face and who, in the opinion of the Investigator, will benefit cosmetically from such a procedure. - Able to understand the requirements of the study and sign Informed Consent and Photography Release forms. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are 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 and/or quality of photography. - Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin - Previous cosmetic surgery to the upper face (e.g., periorbital surgery, brow lift, eyelid or eyebrow surgery, etc.). - Laser resurfacing, dermabrasion, or soft tissue augmentation in the frontal glabellar 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. - 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 the study medication (Section 5.2). - Previous botulinum toxin therapy of any serotype for any reason within six (6) months of the Baseline/Screening Visit. - Evidence of recent alcohol or drug abuse. - Medical and/or psychiatric problems that, in the Investigator’s opinion, are severe enough to interfere with the study results. - History of poor cooperation, non-compliance with medical treatment, or unreliability. - Participation in an investigational drug study within 30 days of the Baseline Visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety and efficacy of Dysport® and BOTOX® in the treatment of subjects desiring brow lift. Particular emphasis will be made on the differences in brow position and the incidence of ptosis. ;Secondary Objective: N/A;Primary end point(s): Pilot Study - Primary endppoint: Brow position. Other endpoints: - Global Assessment of Improvement - Injection Pain | — |
Countries
Belgium
Outcome results
None listed