Glabella frown lines MedDRA version: 16.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Azzalure®
Product Name: Azzalure®
Product Code: Not applicable
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: CLOSTRIDIUM BOTULINUM TYPE A TOXIN-HAEMAGGLUTININ
Sponsors
Q-MED AB
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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 ;Secondary Objective: Not Applicable;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;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Sweden
Contacts
Public ContactHead of Medical Affairs
Q-Med AB
Outcome results
None listed