Glabellar Frown LinesPhase 2NCT03736928
Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines
A Phase 2 study testing AbobotulinumtoxinA dose level 1 or 2, AbobotulinumtoxinA dose 3 and AbobotulinumtoxinA dose 4 in people with Glabellar Frown Lines, run by Galderma R&D at 10 sites in United States.
Trial summary
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- AbobotulinumtoxinA dose level 1 or 2, AbobotulinumtoxinA dose 3 and AbobotulinumtoxinA dose 4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 401 participants
- Where
- 10 sitesUnited States
- Study dates
- 26 Nov 2018to 20 Aug 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
- Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale
Who cannot join
- Botulinum toxin treatment in the face within 9 months prior to study treatment
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Galderma Research Site
Chapel Hill, North Carolina, 27517
Galderma Research Site
Charlotte, North Carolina, 28207
Galderma Research Site
Chicago, Illinois, 60611
Galderma Research Site
Coral Gables, Florida, 33146
Galderma Research Site
Encino, California, 91436
Galderma Research Site
Manhattan Beach, California, 90266
Galderma Research Site
Mequon, Wisconsin, 53092
Galderma Research Site
New Orleans, Louisiana, 70130
Galderma Research Site
New York, New York, 10028
Galderma Research Site
Vista, California, 92083
About this study
Official title: A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
- Conditions
- Glabellar Frown Lines
- Being tested
- AbobotulinumtoxinA dose level 1 or 2, placebo, AbobotulinumtoxinA dose 3, AbobotulinumtoxinA dose 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbobotulinumtoxinA dose level 1 or 2Biological
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
placeboOther
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose 3Biological
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
AbobotulinumtoxinA dose 4Biological
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intramuscular single treatment Receives: Other: placebo |
| AbobotulinumtoxinA dose level 1 or 2 | Experimental | Intramuscular single treatment Receives: Biological: AbobotulinumtoxinA dose level 1 or 2 |
| AbobotulinumtoxinA dose level 3 | Experimental | Intramuscular single treatment Receives: Biological: AbobotulinumtoxinA dose 3 |
| AbobotulinumtoxinA dose level 4 | Experimental | Intramuscular single treatment Receives: Biological: AbobotulinumtoxinA dose 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Composite Responders at Month 1
composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Measured: Month 1 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start26 Nov 2018
- Primary completion9 Dec 2019
- Study completion20 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736928
- Sponsor's protocol ID
- 43USD1801
- Status last verified
- Jan 2021
- First submitted
- 7 Nov 2018
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT03736928
- Acronym / sponsor ID
- 43USD1801
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 20 Aug 2020 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Posted 11 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: placeboIntramuscular single treatment |
| AbobotulinumtoxinA dose level 1 or 2 | Experimental | Biological: AbobotulinumtoxinA dose level 1 or 2Intramuscular single treatment |
| AbobotulinumtoxinA dose level 3 | Experimental | Biological: AbobotulinumtoxinA dose 3Intramuscular single treatment |
| AbobotulinumtoxinA dose level 4 | Experimental | Biological: AbobotulinumtoxinA dose 4Intramuscular single treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
- Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale
Key exclusion criteria (1 listed)
- Botulinum toxin treatment in the face within 9 months prior to study treatment
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 |
|---|---|---|
| AbobotulinumtoxinA dose level 1 or 2Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines | Biological | AbobotulinumtoxinA dose level 1 or 2 |
| placeboIntramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines | Other | Placebo |
| AbobotulinumtoxinA dose 3Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines | Biological | AbobotulinumtoxinA dose level 3 |
| AbobotulinumtoxinA dose 4Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines | Biological | AbobotulinumtoxinA dose level 4 |
Primary outcome
Number of Composite Responders at Month 1
Time frame: Month 1 after treatment
composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AbobotulinumtoxinA dose level 1 or 2, AbobotulinumtoxinA dose 3 and AbobotulinumtoxinA dose 4 in people with Glabellar Frown Lines, run by Galderma R&D at 10 sites in United States.
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 1 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 26 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 10 sites in United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Composite Responders at Month 1 (time frame: Month 1 after treatment). 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 26 Aug 2022.