Severe glabellar rhytids
Conditions
Interventions
Trade Name: BOTOX®
Product Name: BOTOX®
Product Code: N/A
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Cl
Sponsors
Cranley Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Female subjects of any race, between 30 and 50 years of age -Glabellar rhytids -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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pregnant, or 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 -Planned facial cosmetic procedure during the study period or with prior cosmetic procedures or visible scars -Facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, or an inability to substantially lessen upper facial rhytids -Have had previous cosmetic surgery to the upper face -Laser resurfacing, dermabrasion, or soft tissue augmentation in the frontal glabellar periocular area in the 12 months preceding Visit 1 -Any 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 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 -Allergy or sensitivity to any component of the study medication -Have had previous botulinum toxin therapy of any serotype for any reason within 6 months of the Baseline/Screening Visit -Alcohol or drug abuse is evident -Medical and/or psychiatric problems interfering with the study results -History of poor cooperation, non-compliance with medical treatment, or unreliability -Current participation in an investigational drug study or having participated 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 75U Dysport® to 30U BOTOX® in the treatment of subjects with severe glabellar rhytids.;Secondary Objective: N/A; Primary end point(s): – Primary end point: Qualitative Rating of Glabellar Rhytids – Other end points: 1) Brow Position 2) Subject Self-Evaluation Form 3) FLO Questionnaire 4) Facial Wrinkle Scale 5) Injection Pain | — |
Countries
United Kingdom
Outcome results
None listed