E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
To evaluate safety and patient satisfaction of Dysport® compared to BOTOX® in the treatment of upper facial rhytids. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Male or female subjects of any race, between 18 and 65 years of age. - Previously injected by the Investigator with BOTOX® in the glabellar and Crow Feet areas and/or forehead region three to six (3-6) months prior to Visit 1. - Clinical effects of previous BOTOX® therapy have, in the opinion of the Investigators, begun to diminish. - Subjects that are satisfied or extremely satisfied with the clinical effects of their previous BOTOX® therapy. - Able to understand the requirements of the study and provide written informed consent.
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E.4 | Principal exclusion criteria |
- Pregnant (positive urine pregnancy test), are planning to become pregnant during the study period, have an infant they are breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control. - Subjects planning any other facial cosmetic procedure during the study period other than standard facial skin care regimen. - History of marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, excessively thick sebaceous skin, or an inability to substantially lessen upper facial rhytids by physically spreading them apart. - History of eyebrow or eyelid ptosis prior to receiving BOTOX®. - Laser resurfacing, professional dermabrasion or soft tissue augmentation in the upper facial area within 12 months of Visit 1. - Profound atrophy/excessive weakness of muscles in target areas of injection. - History of facial nerve palsy. - Infection at the injection site or systemic infection (in this case, postpone study entry until one week following recovery). - Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function. - Current use of aminoglycoside antibiotics, curare-like agents, or agents that might interfere with neuromuscular (skeletal) function. - Previous exposure to any serotype of botulinum toxin other than BOTOX®. - Allergy or sensitivity to any component of the study medication (Section 5.2). - Uncontrolled systemic disease or with any medical condition or situation that, in the opinion of the Investigator, may put the subject at increased risk. - Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study period (other than study treatment). - Medical and/or psycho-social problems that, in the Investigator’s opinion, are severe enough to interfere with the study results. - Condition or circumstance that, in the Investigator’s opinion, would interfere with the study or its results. - History of poor cooperation, non-compliance with medical treatment, or unreliability. - Participation in an investigational drug study within 30 days of the Baseline Visit.
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E.5 End points |
E.5.1 | Primary end point(s) |
- Subject evaluation of treatment.
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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 | No |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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.8.2.3.1 | Comparator description |
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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 | Information not present in EudraCT |
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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The trial will end on the date of 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 | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |