Glabellar Frown LinesPhase 4NCT02108158
A Safety and Efficacy Study of Different Injections Volumes of Botulinum Toxin Type A, Azzalure, in the Glabellar Lines
A Phase 4 study testing Azzalure in people with Glabellar Frown Lines, run by Galderma R&D at 2 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Azzalure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesSweden
- Study dates
- Apr 2014to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Göteborgs Plastikkirurgiska Center
Gothenburg
Anna Neuromuskulär Konsult
Uppsala
About this study
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
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.
Read the 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
- Being tested
- Azzalure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzzalureDrug
Also called botulinum toxin type A
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Azzalure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown LinesStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Rostedt Punga, MD, Principal investigator, ANNA Neuromuskulär Konsult
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108158
- Sponsor's protocol ID
- 05PF1311
- Other IDs
- 2013-004646-42
- Status last verified
- Aug 2015
- First submitted
- 5 Mar 2014
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02108158
- Acronym / sponsor ID
- 05PF1311
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azzalure 10 Speywood units/injection | Experimental | Drug: AzzalureAzzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U) |
| Azzalure, 10 Speywood units/injection | Active comparator | Drug: AzzalureAzzalure (botulinum toxin type A), powder for solution for injection, Total dose 50 s.U (5 x 10s.U) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzzalureAlso: botulinum toxin type A | Drug | Azzalure 10 Speywood units/injection, Azzalure, 10 Speywood units/injection |
Primary outcome
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)
Time frame: Month 1
To evaluate effect on glabellar line severity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Rostedt Punga, MD principal investigator
ANNA Neuromuskulär Konsult
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azzalure in people with Glabellar Frown Lines, run by Galderma R&D at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.