Glabellar Frown Lines (GL)Phase 3READY-3NCT04247074
Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
A Phase 3 study testing botulinum toxin neuromodulator in people with Glabellar Frown Lines (GL) and Lateral Canthal Lines (LCL), run by Galderma R&D at 12 sites in 2 countries.
Trial summary
This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination. 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 (GL), Lateral Canthal Lines (LCL)
- What is being tested?
- botulinum toxin neuromodulator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 413 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 10 Feb 2020to 26 Feb 2021
- 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 of age or older.
- Moderate to severe LCL at maximum smile as assessed by the Investigator.
- Moderate to severe LCL at maximum smile as assessed by the subject.
- Moderate to severe GL at maximum frown as assessed by the Investigator.
- Moderate to severe GL at maximum frown as assessed by the subject
Who cannot join
- Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- Female who is pregnant, breast feeding, or intends to conceive a child during the study.
- Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
The Westlake Dermatology Clinical Research
Austin, Texas, 78746
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Washington Institute of Dermatologic Laser Surgery
Chevy Chase, Maryland, 20815
Elite Aesthetic Research
Cincinnati, Ohio, 45236
Clinical Testing of Beverly Hills
Encino, California, 91436
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030
Baumann Cosmetic & Research Institute, Inc
Miami, Florida, 33137
Lorenc Aesthetic Plastic Surgery Center
New York, New York, 10028
Skin Specialists, PC
Omaha, Nebraska, 68144
Ava MD
Santa Monica, California, 90404
Skin Care & Laser Physicians of Beverly Hills
West Hollywood, California, 90069
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
- Being tested
- botulinum toxin neuromodulator, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin neuromodulatorBiological
Also called QM1114-DP
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
PlaceboBiological
Placebo will be injected into either the LCL, GL, or both the LCL and GL
| Study group | Role | What they receive |
|---|---|---|
| QM1114-DP in the LCL + Placebo in the GL | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection Receives: Biological: botulinum toxin neuromodulator; Biological: Placebo |
| Placebo in the LCL and GL | Placebo comparator | A buffered solution; Mode of administration:
intramuscular injection Receives: Biological: Placebo |
| Placebo in the LCL + QM1114-DP in the GL | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection Receives: Biological: botulinum toxin neuromodulator; Biological: Placebo |
| QM1114-DP in the LCL + GL | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection Receives: Biological: botulinum toxin neuromodulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown
Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown.
Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).
Measured: Month 1
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile
Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile.
Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.
Measured: Month 1
Secondary outcomes (2)
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
Measured: Month 1
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale 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 posted29 Jan 2020
- Study start10 Feb 2020
- Primary completion2 Oct 2020
- Study completion26 Feb 2021
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 Lines (GL)Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 413 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
- NCT04247074
- Sponsor's protocol ID
- 43QM1902
- Acronym
- READY-3
- Status last verified
- Jun 2023
- First submitted
- 7 Jan 2020
- Last updated
- 6 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
- ClinicalTrials.gov ID
- NCT04247074
- Acronym / sponsor ID
- READY-3 / 43QM1902
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Posted 6 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QM1114-DP in the LCL + Placebo in the GL | Experimental | Biological: botulinum toxin neuromodulator, Biological: PlaceboQM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection |
| Placebo in the LCL and GL | Placebo comparator | Biological: PlaceboA buffered solution; Mode of administration: intramuscular injection |
| Placebo in the LCL + QM1114-DP in the GL | Experimental | Biological: botulinum toxin neuromodulator, Biological: PlaceboQM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection |
| QM1114-DP in the LCL + GL | Experimental | Biological: botulinum toxin neuromodulatorQM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female 18 years of age or older.
- Moderate to severe LCL at maximum smile as assessed by the Investigator.
- Moderate to severe LCL at maximum smile as assessed by the subject.
- Moderate to severe GL at maximum frown as assessed by the Investigator.
- Moderate to severe GL at maximum frown as assessed by the subject
Key exclusion criteria (3 listed)
- Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- Female who is pregnant, breast feeding, or intends to conceive a child during the study.
- Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).
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 neuromodulatorAlso: QM1114-DPQM1114-DP will be injected into either the LCL, GL, or both the LCL and GL | Biological | Placebo in the LCL + QM1114-DP in the GL, QM1114-DP in the LCL + GL, QM1114-DP in the LCL + Placebo in the GL |
| PlaceboPlacebo will be injected into either the LCL, GL, or both the LCL and GL | Biological | Placebo in the LCL + QM1114-DP in the GL, Placebo in the LCL and GL, QM1114-DP in the LCL + Placebo in the GL |
Primary outcome
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown
Time frame: Month 1
Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown. Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile
Time frame: Month 1
Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile. Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.
2 secondary outcomes
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
Time frame: Month 1
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.
Time frame: Month 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing botulinum toxin neuromodulator in people with Glabellar Frown Lines (GL) and Lateral Canthal Lines (LCL), run by Galderma R&D at 12 sites in 2 countries.
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 5 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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 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 6 Sep 2023). 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?
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown (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 6 Sep 2023.