Moderate to severe glabellar lines, as assessed by Facial Wrinkle Scale with Photonumeric Guide (FWS) at full contraction
Conditions
Interventions
Trade Name: VISTABEL 4 Allergan-Einheiten/0,1 ml Pulver zur Herstellung einer Injektionslösung
Pharmaceutical Form: Powder for solution for injection
CAS Number: 93384-43-1
Other descriptive name: BO
Sponsors
Allergan Pharmaceuticals Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 to 65 years old at study entry. 2. Moderate to severe glabellar frown lines at maximum frown as assessed by the investigator according to FWS 3. Willing and able to complete the entire course of the trial and to comply with trial instructions 4. Written Informed Consent 5. Negative urine pregancy test for all women of child bearing potential 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: 1. Treatment with Vistabel® or Bocouture® would meet any of the contraindications on the Vistabel® or Bocoture® SMPCs, namely: a. Allergy or hypersensitivity to Botulinum Toxin type A or to any excipients of the Vistabel® or Bocoture® formulations. b. Presence of any disease affecting muscular function eg: myasthenia gravis, Eaton Lambert syndrome. c. Presence of infection at the proposed injection site. 2. Previous aesthetic treatment with Botulinum toxin within the last 6 months or planned within the study period. 3. Any previous treatments with fillers in the glabellar area. 4. Any previous insertion of permanent material in the glabellar area 5. Any previous surgery within the glabellar region 6. Previous treatment with any facial cosmetic procedure in the glabellar area within the last 6 months, or planned within the study period. 7. Planned treatment with Botulinuin toxin in any other body region during the study period 8. Inability to substantially lessen glabellar frown lines even by physically spreading them apart, or glabellar lines at rest of FWS grade 3 9. Marked facial asymmetry or ptosis of eyelid and/or eyebrow 10. History of facial nerve palsy 11. Bleeding disorders or regular intake of drugs with anticoagulative effect within the last 10 days before Screening 12. Concurrent or planned use of aminoglycoside antibiotics or other agents that might interfere with neuromuscular function (e.g. D-penicillinamine, curarine-type muscle relaxants, succinylcholine) or that might interfere with the action of Botulinum toxin (e.g. chloroquine) 13. Psychiatric problems that, in the investigator's opinion, are severe enough to interfere with trial results 14. Females of childbearing potential that are: a. Pregnant b. Nursing c. planning pregnancy during the trial period d. not using appropriate methods of contraception 15. Known allergy or sensitivity to the trial medication or its components 16. Participation in another clinical trial within 30 days prior to screening 17. Any medical or psychiatric problem that, in the opinion of the investigator may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Vistabel® (20 units) in the treatment of moderate to severe glabellar lines, when compared to Bocouture® (30 units). ;Secondary Objective: N/A;Primary end point(s): Injector’s assessment of the severity of glabellar lines at maximum contraction using the FWS at Day 28. Treatment response is defined as achievement of 1 point or greater reduction in FWS at maximum contraction. | — |
Countries
Germany
Outcome results
None listed