E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Glabella frown lines |
Glabellaveck |
|
E.1.1.1 | Medical condition in easily understood language |
Glabella frown lines |
Glabellaveck |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052609 |
E.1.2 | Term | Glabellar frown lines |
E.1.2 | System Organ Class | 100000004858 |
|
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 the compound muscle action potential (CMAP) using electroneurography
- To assess the severity of glabellar lines, live and from photographs and video, at rest and at maximum frown
- To assess the subject’s satisfaction with the treatment by using the Subject Satisfaction Questionnaire
- To evaluate the subjects experience of onset of effect by response to the question “Since being injected, have you noticed any effect on the appearance of your glabellar lines?”
- To evaluate the safety of two different injection volumes of Azzalure® in the glabellar lines by collecting Adverse Events
- To evaluate the subjects pain on injection using the Visual Analogue Scale |
- att utvärdera CMAP (compound muscle action potential) med hjälp av elektroneurografi
- att utvärdera graden av glabellarynkan vid vila och vid maximal kontraktion
- att utvärdera försökpersonens nöjdhet med behandlingen genom att använda en nöjdhetsenkät
- att utvärdera försökspersonernas upplevelse av insättande av effekt
- att utvärdera säkerheten av två olika injektionsvolymer av Azzalure® i glabellarynkan genom att samla biverkningar
- att utvärdera försökspersonernas smärta efter injektion genom att använda en VAS (Visual Analogue Scale) |
|
E.2.2 | Secondary objectives of the trial |
Not Applicable |
Ej aktuellt |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Women, 18 to 64 years of age (at screening visit).
2. Subjects seeking treatment for moderate to severe glabellar lines (grade 2-3 at rest using ‘Merz Aestethic Scale for Glabellar lines at rest’) when the severity of these lines has an important psychological impact on the subject, as determined by the investigator.
|
1. Kvinnor, 18-64 år (vid urvalsbesöket)
2. Försökspersoner som söker behandling för uttalade till allvarliga glabellaveck (grad 2-3 på Merz skala för glabellaveck vid avslappning) i de fall rynkorna har en betydande psykologisk påverkan på patienten, enligt rekryterande läkare
|
|
E.4 | Principal exclusion criteria |
1. Subjects previously treated with any botulinum toxin product.
2. Pregnant or breast feeding women or women intending to get pregnant in the next 12 months.
3. Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
4. Subjects with clinical or subclinical neuromuscular junctional disorders (e.g. myasthenia gravis, Lambert Eaton syndrome or amyotrophic lateral sclerosis) or a history of dysphagia or aspiration.
5. Subjects with previous or current diagnosis of Bell’s paresis.
6. Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
7. Subjects who are taking anticholinergics or aminoglycoside antibiotics.
8. Subjects with active inflammation or infection in the areas to be treated.
9. Subjects with known hypersensitivity to any compound of the study products used in the study.
10. Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results.
11. Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening.
|
1. Försökspersoner tidager behandlade med botulinumtoxinprodukter
2. Gravida eller ammande kvinnor eller kvinnor som avser att bli gravida inom 12 månader
3. Försökspersoner med tecken och symptom på ögonlocks- eller ögonbrynsptos eller tecken på kompensatorisk muskelaktivitet i frontalis, enligt prövarens bedömning.
4. Försökspersoner med kliniska eller subkliniska störningar i de neuromuskulära kopplingarna (till exempel myastenia gravis, Lambert Eatons syndrom eller amyotrofisk lateral scleros) eller en historia av dysfagi eller aspiration
5. Försökspersoner med tidigare eller aktuell diagnos av Bell's pares
6. Försökspersoner med kända blödningsrubbningar eller försökspersoner som tar trombolytika eller antikoagulantia.
7. Försökspersoner som tar antikolinergika eller aminoglykosid antibiotika.
8. Försökspersoner med aktiv inflammation eller infektion i behandlingrområdet.
10. Tidigare kirurgi i ansiktet som, enligt prövarens bedömning, kan påverka studiens resultat.
11. Försökspersoner som behandlats med fillers, HA fillers eller permanenta fillers, i övre delen av ansiktet mindre än 1 år innan screeing. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- CMAP as % of baseline value
- Wrinkle severity as change from baseline
- Subject Satisfaction Questionnaire, as change from baseline
- Subject experience of onset of effect (YES response to question)
- AEs
- VAS scores |
- CMAP som % av baselinevärdet
- Graden av glabellarynkan som förändring från baseline
- Frågeformulär om försökspersonens nöjdhet som förändring från baseline
- Försökspersonens upplevelse av insättande av effekt (Ja som svar på frågan)
- Biverkningar
- VAS scores |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
-CMAP: Visit 0, 1, 2, 3, 5, 6 and 8
- Wrinkle severity: all visits
- Subject Satisfaction: Visit 0, 5, 6 and 8
- Subject experience of onset: Visit 1-5 until respons is YES
- AEs: all visits after screening
- VAS score: Visit 0 |
-CMAP: Besök 0, 1, 2, 3, 5, 6 och 8
- Wrinkle severity: alla besök
- Försökspersonens nöjdhet: Besök 0, 5, 6 och 8
- Försökspersonens upplevelse av insättande av effekt: Besök 1-5 tills svaret är JA
- Biverkningar: alla besök efter screening
- VAS score: Visit 0 |
|
E.5.2 | Secondary end point(s) |
Not applicable |
Ej aktuellt |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Ej aktuellt |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
utvärderarblindad |
evaluator-blinded |
|
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 |
Azzalure, dos och injektionsvolym enligt godkänd indikation |
Azzalure, dose and injection volume according to label |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 2 |
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 | No |
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
|
Last Subject Last Visit |
Sista Försökspersonens Sista Besök |
|
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 | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 10 |