Glabellar Frown LinesPhase 3NCT05148000
Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
A Phase 3 study testing QM1114-DP in people with Glabellar Frown Lines and Canthal Lines, run by Galderma R&D at 1 site in United States.
Trial summary
This study to assess aesthetic improvement following treatment with QM1114-DP. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glabellar Frown Lines, Canthal Lines
- What is being tested?
- QM1114-DP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 23 Jun 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female 18 years or older
- Moderate to severe bilaterally symmetrical LCL as assessed by the investigator
- Moderate to severe GL at maximum frown as assessed by the Investigator
Who cannot join
- Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
- Female who was pregnant, breast feeding or intended to conceive a child during the study.
- Known allergy to hypersensitivity or any component of the Investigational product
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label Study to Assess Aesthetic Improvement Following Treatment With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
This study to assess aesthetic improvement following treatment with QM1114-DP.
Read the detailed description
This was an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.
- Conditions
- Glabellar Frown Lines, Canthal Lines
- Being tested
- QM1114-DP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QM1114-DPBiological
QM1114-DP
| Study group | Role | What they receive |
|---|---|---|
| QM1114-DP | Experimental | QM1114-DP Receives: Biological: QM1114-DP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines)
The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your glabellar lines (lines between your eyebrows) at maximum frown compared with immediately before the injection?". Participants were then instructed to select on rating that best describes the degree to which the appearance of their glabellar lines at maximum frown has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum frown.
Measured: Month 1
Responders Rate Using the GAIS at Maximum Smile (Lateral Canthal Lines)
The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your lateral canthal lines (crow's feet) at maximum smile compared with immediately before the injection". Participants were then instructed to select on rating that best describes the degree to which the appearance of their lateral canthal lines at maximum smile has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum smile.
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 posted7 Dec 2021
- Study start23 Jan 2023
- Primary completion31 Mar 2023
- Study completion23 Jun 2023
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT05148000
- Sponsor's protocol ID
- 43QM2107
- Status last verified
- Mar 2026
- First submitted
- 31 Oct 2021
- Last updated
- 29 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Assess Aesthetic Improvement Following Treatment With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines
- ClinicalTrials.gov ID
- NCT05148000
- Acronym / sponsor ID
- 43QM2107
- Conditions
- Glabellar Frown Lines, Canthal Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 23 Jun 2023 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study to assess aesthetic improvement following treatment with QM1114-DP.
Detailed description
This was an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
| Arm | Type | Receives |
|---|---|---|
| QM1114-DP | Experimental | Biological: QM1114-DPQM1114-DP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female 18 years or older
- Moderate to severe bilaterally symmetrical LCL as assessed by the investigator
- Moderate to severe GL at maximum frown as assessed by the Investigator
Key exclusion criteria (3 listed)
- Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
- Female who was pregnant, breast feeding or intended to conceive a child during the study.
- Known allergy to hypersensitivity or any component of the Investigational product
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 |
|---|---|---|
| QM1114-DPQM1114-DP | Biological | QM1114-DP |
Primary outcome
Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines)
Time frame: Month 1
The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your glabellar lines (lines between your eyebrows) at maximum frown compared with immediately before the injection?". Participants were then instructed to select on rating that best describes the degree to which the appearance of their glabellar lines at maximum frown has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum frown.
Responders Rate Using the GAIS at Maximum Smile (Lateral Canthal Lines)
Time frame: Month 1
The GAIS is a 7-point scale ranging from 1 to 7 where 1 = "very much improved", 2 = "much improved", 3 ="improved", 4 = "no change", 5 = "worse", 6 = "much worse" and 7 = "very much worse". Participants were asked "How would you rate the change in appearance of your lateral canthal lines (crow's feet) at maximum smile compared with immediately before the injection". Participants were then instructed to select on rating that best describes the degree to which the appearance of their lateral canthal lines at maximum smile has changed relative to baseline. The participant could review the baseline photographs to aid in the assessment. Responder rate is defined as percentage of participants who responds at least "Improved" (i.e., improved, much improved and very much improved) on the GAIS at maximum smile.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QM1114-DP in people with Glabellar Frown Lines and Canthal Lines, run by Galderma R&D at 1 site 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 3 inclusion and 3 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 29 May 2026). 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?
Responders Rate Using the Global Aesthetic Improvement Scale (GAIS) at Maximum Frown (Glabellar Lines) (time frame: Month 1). The study lists 2 primary outcomes in all. 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 29 May 2026.