Upper face rhytids
Conditions
Interventions
Trade Name: Dysport®
Product Name: Dysport®
Product Code: N/A
Pharmaceutical Form: Injection*
INN or Proposed INN: Clostridium type A toxin - hemagglutinin complex
CAS Number: N/A
Current Sponsor code
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. - Previously injected by the Investigator with BOTOX® in the glabellar and Crow Feet areas and/or forehead region three to six (3-6) months prior to Visit 1. - Clinical effects of previous BOTOX® therapy have, in the opinion of the Investigators, begun to diminish. - Subjects that are satisfied or extremely satisfied with the clinical effects of their previous BOTOX® therapy. - Able to understand the requirements of the study and provide written informed consent. 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) no 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 any other facial cosmetic procedure during the study period other than standard facial skin care regimen. - History of marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or an inability to substantially lessen upper facial rhytids by physically spreading them apart. - History of eyebrow or eyelid ptosis prior to receiving BOTOX®. - Laser resurfacing, professional dermabrasion or soft tissue augmentation in the upper facial area within 12 months of Visit 1. - 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). - 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. - Previous exposure to any serotype of botulinum toxin other than BOTOX®. - Allergy or sensitivity to any component of the study medication (Section 5.2). - Uncontrolled systemic disease or with any medical condition or situation that, in the opinion of the Investigator, may put the subject at increased risk. - Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study period (other than study treatment). - Medical and/or psycho-social problems that, in the Investigator’s opinion, are severe enough to interfere with the study results. - Condition or circumstance that, in the Investigator’s opinion, would interfere with the study or its 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 evaluate safety and patient satisfaction of Dysport® compared to BOTOX® in the treatment of upper facial rhytids.;Secondary Objective: N/A;Primary end point(s): - Subject evaluation of treatment. | — |
Countries
Belgium
Outcome results
None listed