Moderate to severe glabellar frown lines MedDRA version: 8.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines
Conditions
Interventions
Trade Name: Xeomin
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: 011368 001 01
CAS Number: 8000049323
Other descriptive name: Botulinum toxin type a
Concentration unit: IU internatio
Sponsors
Dermatologikum Hamburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between 18 and 75 years of age with moderate to severe glabellar frown lines (severity score = 2 as assessed by the investigator according to Facial Wrinkle Scale) 2. Stable medical condition 3. Subject willing and able to realize the entire course of trial and to comply with trial instructions 5. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous treatment with Botulinum toxin in the glabellar area within the last 6 months prior to study start 2. Any previous insertion of permanent filler material in the glabellar area 3. Previous treatments with facial cosmetic procedures (e.g. dermal filling, chemical peeling, photo rejuvenation) in the glabellar area within the last 9 months prior to study start 4. Planned treatment with Botulinum toxin in any additional body region during the study period 5. Planned additional treatment with any facial cosmetic procedure (e.g. dermal filling, chemical peeling, photo rejuvenation) in the glabellar area during the study participation 6. Any surgical pretreatment or scars in the glabellar area 7. Any infection in the area of the injection sites 8. Known allergy or sensitivity to the trial medication or its components, or any medical condition that may expose the subject to an increased risk by exposure to Xeomin including diagnosed myasthenia gravis, Lambert-Eaton Syndrome, amyotrophic lateral sclerosis or any other disorder that might interfere with neuromuscular function 9. History of facial nerve palsy 10. Bleeding disorders or regular intake of drugs with anticoagulative effect within the last 10 days prior to study start 11. Concurrent use of aminoglycosides (antibiotics) or other agents that might interfere with neuromuscular function or action of Botulinum toxin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate group differences in the treatment with two different Xeomin dilutions with regard to photo documentation ;Secondary Objective: Efficacy and safety of the two different Xeomin dilutions;Primary end point(s): Global assessment of the glabella frown lines by FWS based on photo documentation | — |
Countries
Germany
Outcome results
None listed