A Prospective Evaluation of BOTOX® and Dysport® in Temporal Brow Elevation - BOTOX® vs. Dysport® in Brow Lift
- Conditions
- For subjects who desire brow lift as a means to rejuvenate the upper face.
- Registration Number
- EUCTR2005-005252-40-BE
- Lead Sponsor
- Aalst Dermatology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>;Secondary Objective: N/A;Primary end point(s): Pilot Study - Primary endppoint: Brow position. <br>Other endpoints:<br>- Global Assessment of Improvement<br>- Injection Pain<br>
- Secondary Outcome Measures
Name Time Method