E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to severe vertical glabellar lines.
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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 | 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 |
The main objective is the assessment of the relative clinical safety of the two different presentations (125 U vial (referred to as Reloxin) and 500 U vial (Dysport®)) by comparison of the incidence and severity of AEs, vital signs and concomitant medications.
Because the presentations have different excipient concentrations when reconstituted, this pilot study is necessary to demonstrate that the effect in man of the new presentation (125 units, referred to as Reloxin) is not different to that of the reference product (500 units, Dysport®), which is registered for this indication in Germany.
The long term aim is to register and market a presentation that has a more appropriate dose and therefore is more suitable for treatment of facial lines. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess the relative clinical efficacy of the two different presentations in terms of the proportion of responders showing a reduction of glabellar lines, based on investigator and subject assessments performed at maximum frown and investigator assessments performed at rest.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects between 18 and 65 years of age;
2. Moderate to severe vertical glabellar lines at maximum frown (score of 2 or 3 by the subject's static self-assessment and confirmed by the Investigator’s live assessment, using a 4-point categorical scale (no wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles [3]);
3. Negative pregnancy test result for females of childbearing potential;
4. Time and ability to complete the study and comply with instructions;
5. Understanding of the study and the contents of the informed consent documents. All subjects must provide written informed consent before enrolling into the study. |
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E.4 | Principal exclusion criteria |
(1) Previous treatment with Dysport or any other botulinum toxin or toxin treatment to any areas of the body at any time prior to the study or planned during the study; (2) Inability to substantially lessen glabellar lines by physically spreading them apart; (3) Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication; (4) Active infection in the glabellar area (e.g., acute acne lesions); (5) Pregnant women, nursing mothers, or women who are planning pregnancy during the study, or who think that they might be pregnant at the start of the study. (6) Current history of chronic drug or alcohol abuse; (7) Enrolment in any active study involving the use of investigational devices or drugs within 90 days of the screening visit; (8) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin; (9) Neuromuscular junctional disorders (e.g., myasthenia gravis); (10) Known allergy or hypersensitivity to any botulinum toxin or any component of Reloxin or Dysport; (11) Concurrent use of medications that affect neuromuscular transmission, such as lincosamides, polymyxins, and aminoglycoside antibiotics affecting the striated muscle; (12) Presence of any other condition (e.g., neuromuscular disorder or other disorder that could interfere with neuromuscular function) or circumstance that, in the judgment of the Investigator, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study; (13) Is likely to require treatment during the study with drugs that are not permitted by the study protocol. (14) Subjects must not be confined in an institution due to court or administrative order. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary (safety) endpoints are: • Incidence of AEs (including information on intensity, drug relationship and AEs leading to withdrawals) at pre-treatment and on Days 1, 4, 8, 15, 29, 57, 85 and 113; • Assessment of vital signs at pre-treatment and on Days 1, 4, 8, 15, 29, 57, 85 and 113, (in terms of absolute values and changes from baseline); • Use of concomitant medications at pre-treatment and on Days 1, 4, 8, 15, 29, 57, 85 and 113. |
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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) | 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 | 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
| 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 | 5 |
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 | 5 |
E.8.9.1 | In the Member State concerned days | |