E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe crow`s feet |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052611 |
E.1.2 | Term | Crow's feet |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate group differences in the treatment of crows feet with Xeomin and Dysport with regard to photo documentation |
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E.2.2 | Secondary objectives of the trial |
The efficacy and safety of the two different treatments (Xeomin vs. Dysport) will be assessed. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Global assessment of the crow`s feet by FWS based on photo documentation (laughing condition) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |