A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines

Galderma

Status and phase

Completed

Phase 4

Conditions

Glabellar Frown Lines

Treatments

Drug: Azzalure

Study type

Interventional

Funder types

Industry

Identifiers

NCT02108158

05PF1311

2013-004646-42 (EudraCT Number)

Details and patient eligibility

About

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

Full description

Clarification regarding injection volumes for the different study groups:

Subjects will be randomized to Group A or Group B (1:1).

Group A: 0,63ml NaCl will be used to reconstitute toxin in the vial. 0,05mL will be injected (equal to a dose of 10s.U.)
Group B: 1,25ml NaCl will be used to reconstitute toxin in the vial. 0,1 mL will be injected (equal to a dose of 10s.U.).

The two different reconstitution volumes (each containing a dose of 10s.U. botulinum toxin A) will be compared as described under objectives.

Enrollment

62 patients

Sex

Female

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Women, 18 to 64 years of age
Subjects seeking treatment for moderate to severe glabellar lines when the severity of these lines has an important psychological impact on the subject, as determined by the investigator.

Key Exclusion Criteria:

Subjects previously treated with any botulinum toxin product.
Pregnant or breast feeding women or women intending to get pregnant in the next 12 months.
Subjects with signs and symptoms of eyelid or brow ptosis or signs of compensatory frontalis muscle activity, as judged by the investigator.
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.
Subjects with previous or current diagnosis of Bell's paresis.
Subjects with known bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
Subjects who are taking anticholinergics or aminoglycoside antibiotics.
Any prior surgery in the facial area that, in the opinion of the investigator, may interfere with the results.
Subjects treated with fillers, HA filler or permanent filler, in the upper face one year or less from screening.