E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe glabellar frown lines |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052609 |
E.1.2 | Term | Glabellar frown lines |
|
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 with two different Xeomin dilutions with regard to photo documentation |
|
E.2.2 | Secondary objectives of the trial |
Efficacy and safety of the two different Xeomin dilutions |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Global assessment of the glabella frown lines by FWS based on photo documentation |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Different dilutions of Xeomin in sodium chloride 0,9% solution |
|
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
| |
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 | |