E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe Lateral Canthal Lines
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052609 |
E.1.2 | Term | Glabellar frown lines |
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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 |
Part A: initial treatment in CL (placebo-controlled):
- To assess the efficacy, safety and duration of effect of Azzalure® compared to placebo in the improvement of moderate to severe Lateral Canthal Lines.
- To assess the subjects’ level of satisfaction with the appearance their Lateral Canthal Lines compared to placebo.
Part B: repeated treatment in CL with or without GL (active treatment, up to 1 year):
- To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe Lateral Canthal Lines.
- To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe Lateral Canthal Lines and Glabellar Lines.
- To assess the subjects’ level of satisfaction with the appearance their Lateral Canthal Lines.
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E.2.2 | Secondary objectives of the trial |
Secondary efficacy objectives: Key secondary: To determine the subjects’ level of satisfaction with the appearance of their CL following treatment with Azzalure® compared with placebo at Week 4 and similarly up Week 16.
Other secondary: To determine the efficacy of Azzalure® in the improvement of CL “at rest” compared with placebo at Week 4, and similarly up to Week 16.
To determine the safety of Azzalure® - compared with placebo up to 12 weeks - following repeated administration in CL up to 1 year - when used concomitantly in CL and GL
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female subjects, 18 to 65 years of age with moderate or severe (grade 2 or 3) Lateral Canthal Lines at maximum smile and with mild to severe (grade 1, 2, or 3) Lateral Canthal Lines at rest. |
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E.4 | Principal exclusion criteria |
Subjects who had any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the study results will not be included in this study |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint: To determine the efficacy of Azzalure® (30 S.U./half face) in the improvement, from baseline to Week 4, of moderate to severe CL “at maximum smile” compared with placebo. In order to determine the duration of effect, the efficacy of Azzalure® in the improvement of moderate to severe CL “at maximum smile” will be compared with placebo at Week 8, 12 and 16. |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |