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

NCT ID: NCT02108158

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Detailed 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.

Conditions

Glabellar Frown Lines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Azzalure 10 Speywood units/injection

Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)

Group Type: EXPERIMENTAL

Azzalure

Intervention Type: DRUG

Azzalure, 10 Speywood units/injection

Azzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U)

Group Type: ACTIVE_COMPARATOR

Azzalure

Intervention Type: DRUG

Interventions

Azzalure

Intervention Type: DRUG

Other Intervention Names

botulinum toxin type A

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Rostedt Punga, MD

Role: PRINCIPAL_INVESTIGATOR

ANNA Neuromuskulär Konsult

Locations

Göteborgs Plastikkirurgiska Center

Gothenburg, , Sweden

Anna Neuromuskulär Konsult

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

2013-004646-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

05PF1311

Identifier Type: -

Identifier Source: org_study_id