NCT02108158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2014

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

March 5, 2014

Last Update Submit

August 24, 2022

Conditions

Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (3)

  • Assessment of severity of glabellar lines at rest and at maximum frown using the Merz Aesthetic 5-point scale

    Day 0, 1, 3, 7, 14, month 3, 4 and 6

  • Adverse Event reporting

    Day 0-180

  • Compound Muscle Action Potential (CMAP) reduction as percent of baseline CMAP measurement

    Day 0, 1, 3, 7, month 1, 3 and 6

Study Arms (2)

Azzalure 10 Speywood units/injection

EXPERIMENTAL

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

Drug: Azzalure

Azzalure, 10 Speywood units/injection

ACTIVE COMPARATOR

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

Drug: Azzalure

Interventions

AzzalureDRUG
Also known as: botulinum toxin type A
Azzalure 10 Speywood units/injectionAzzalure, 10 Speywood units/injection

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Göteborgs Plastikkirurgiska Center

Gothenburg, Sweden

Location

Anna Neuromuskulär Konsult

Uppsala, Sweden

Location

MeSH Terms

Interventions

abobotulinumtoxinABotulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Anna Rostedt Punga, MD

    ANNA Neuromuskulär Konsult

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 25, 2022

Record last verified: 2015-08

Locations

SE(2)