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

Glabellar Frown Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108158
• Other study ID #: 05PF1311
• Secondary ID: 2013-004646-42
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• Azzalure

Locations

Country	Name	City	State
Sweden	Göteborgs Plastikkirurgiska Center	Gothenburg
Sweden	Anna Neuromuskulär Konsult	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale	To evaluate effect on glabellar line severity	Day 0, 1, 3, 7, 14, month 3, 4 and 6
Other	Adverse Event reporting	To evaluate long term safety throughout the study period	Day 0-180
Other	Compound Muscle Action Potential (CMAP) reduction as percent of baseline CMAP measurement	To evaluate the Compound Muscle Action Potential using electroneurography	Day 0, 1, 3, 7, month 1, 3 and 6
Primary	Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale. (However no primary outcome measure is defined in the study protocol)	To evaluate effect on glabellar line severity	Month 1