Glabellar Frown LinesPhase 2NCT02236312
Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines
A Phase 2 study testing Botulinum Toxin Type A in people with Glabellar Frown Lines, run by Galderma R&D at 8 sites in United States.
Trial summary
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Botulinum Toxin Type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 359 participants
- Where
- 8 sitesUnited States
- Study dates
- Sep 2014to May 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest
Who cannot join
- Any previous treatment with any botulinum toxin
- Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
- Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
- Any history of facial surgery above the lower orbital rim
- Any planned facial surgery or aesthetic procedure during the study period
- Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Private practice
Aventura, Florida
Private practice
Birmingham, Alabama
Private practice
Englewood, Colorado
Private practice
Mobile, Alabama
Private practice
Nashville, Tennessee
Private practice
Salt Lake City, Utah
Private practice
San Antonio, Texas
Private practice
San Diego, California
About this study
Official title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botulinum Toxin Type A, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin 30 units | Experimental | I.M. injection Receives: Drug: Botulinum Toxin Type A |
| Botulinum Toxin 45 units | Experimental | I.M. injection Receives: Drug: Botulinum Toxin Type A |
| Botulinum Toxin 60 units | Experimental | I.M. injection Receives: Drug: Botulinum Toxin Type A |
| Placebo | Placebo comparator | I.M. injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin
Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionMay 2015
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 359 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
- NCT02236312
- Sponsor's protocol ID
- 43QM1313
- Status last verified
- May 2016
- First submitted
- 1 Sep 2014
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
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 Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines
- ClinicalTrials.gov ID
- NCT02236312
- Acronym / sponsor ID
- 43QM1313
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Sep 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.
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin 30 units | Experimental | Drug: Botulinum Toxin Type AI.M. injection |
| Botulinum Toxin 45 units | Experimental | Drug: Botulinum Toxin Type AI.M. injection |
| Botulinum Toxin 60 units | Experimental | Drug: Botulinum Toxin Type AI.M. injection |
| Placebo | Placebo comparator | Drug: PlaceboI.M. injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest
Key exclusion criteria (6 listed)
- Any previous treatment with any botulinum toxin
- Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
- Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
- Any history of facial surgery above the lower orbital rim
- Any planned facial surgery or aesthetic procedure during the study period
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 |
|---|---|---|
| Botulinum Toxin Type A | Drug | Botulinum Toxin 30 units, Botulinum Toxin 45 units, Botulinum Toxin 60 units |
| Placebo | Drug | Placebo |
Primary outcome
Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin
Time frame: 14 Days
Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.
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 26 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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 Botulinum Toxin Type A in people with Glabellar Frown Lines, run by Galderma R&D at 8 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 1 inclusion and 6 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 8 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?
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?
Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin (time frame: 14 Days). 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.