Moderate to severe crow`s feet MedDRA version: 9.1 Level: LLT Classification code 10052611 Term: Crow's feet
Conditions
Interventions
Trade Name: Xeomin
Pharmaceutical Form: Powder for injection*
Other descriptive name: BOTULINUM TOXIN TYPE A
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 100-
Trade N
Sponsors
Dermatologikum Hamburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female and male subjects with moderate to severe crow`s feet (severity score of 2 and 3 as assessed by the investigator according to Facial Wrinkle Scale) aged between18 and 65 years • Stable medical condition • Able to comply with the requirements of this study protocol • Written informed consent and data protection statement 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: • Treatment of the upper face with botulinum toxin within 6 month prior to study entry • Pretreatment with any permanent filler material in the area to be treated • Any cosmetic pretreatment in the area to be treated (e.g. facial injections of dermal fillers, chemical peeling or photo rejuvenation) within 9 month prior to study entry • Any additional intended treatment with botulinum toxin in a further localization during the study • Any additional intended cosmetic treatment in the area to be treated (e.g. facial injections of dermal fillers, chemical peeling or photo rejuvenation) during the study • Any prior surgery or scars in the area to be treated • Infections of the injection areas • Known adverse reactions of any severity or hypersensitivity to any ingredient of Xeomin® or any medical condition with increased risk by exposure to Xeomin, including Myasthenia gravis, Lambert-Eaton Syndrome, Amyotrophic lateral sclerosis or any other interferences with impairment of neuromuscular functions • Known adverse reactions of any severity or hypersensitivity to any ingredient of Dysport® respectively or any medical condition with increased risk by exposure to botulinum toxin A, including Myasthenia gravis, Lambert-Eaton Syndrome, Amyotrophic lateral sclerosis or any other interferences with impairment of neuromuscular functions • Palsy of facial nerves • Coagulation disorders or regular administration of drugs with anticoagulative effect within 10 days prior to study • Administration of aminoglycosides (antibiotics) or other drugs that may interfere with neuromuscular functions or the efficacy of botulinum toxin • Alcohol and drug abuse • Pregnant or breastfeeding women and women who are planning to become pregnant or women of childbearing potential that do not use adequate birth control measures during the trial • Participation in any other clinical trial within 30 days prior or during this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate group differences in the treatment of crows feet with Xeomin and Dysport with regard to photo documentation;Secondary Objective: The efficacy and safety of the two different treatments (Xeomin vs. Dysport) will be assessed.;Primary end point(s): Global assessment of the crow`s feet by FWS based on photo documentation (laughing condition) | — |
Countries
Germany
Outcome results
None listed