A randomized, evaluator-blinded, comparative study toevaluate the efficacy and safety of different injection volumes of botulinum toxin type A, Azzalure®, in the glabellar lines.

• Conditions: Glabella frown lines; MedDRA version: 16.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-004646-42-SE
• Lead Sponsor: Q-MED AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-19
• Last Update Posted: 16 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified