Glabellar Frown LinesPhase 3READY-1NCT04249583
Treatment of Moderate to Severe Glabellar Lines
A Phase 3 study testing botulinum toxin in people with Glabellar Frown Lines, run by Galderma R&D at 14 sites in 2 countries.
Trial summary
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL. 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
- What is being tested?
- botulinum toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 10 Feb 2020to 5 Jan 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 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) or any botulinum toxin serotype.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
Dallas Center for Dermatology & Aesthetics
Dallas, Texas, 75225
Maryland Dermatology, Laser Skin & Vein
Hunt Valley, Maryland, 21030
\Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266
The Practice of Brian S Biesman, MD
Nashville, Tennessee, 37203
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130
Robert Schwarcz, MD, PC
New York, New York, 10021
Sachin M Shridharani, MD
New York, New York, 10021
Skin Specialist, PC
Omaha, Nebraska, 68144
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Integrated Aesthetics, Inc
Spring, Texas, 77388
Moradi MD
Vista, California, 92083
Wilmington Dermatology Center, PLLC
Wilmington, North Carolina, 28405
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 Glabellar Lines
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.
- Conditions
- Glabellar Frown Lines
- Being tested
- botulinum toxin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxinBiological
Also called QM1114-DP
neuromodulator to be injected in the GL region
PlaceboBiological
Placebo to be injected in the GL area
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection Receives: Biological: botulinum toxin |
| Placebo | Placebo comparator | A buffered solution; Mode of administration: intramuscular injection Receives: Biological: Placebo |
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 at One Month.
The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)
Measured: One Month
Secondary outcomes (1)
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start10 Feb 2020
- Primary completion7 Aug 2020
- Study completion5 Jan 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 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
- NCT04249583
- Sponsor's protocol ID
- 43QM1602
- Acronym
- READY-1
- Status last verified
- Sep 2022
- First submitted
- 30 Dec 2019
- Last updated
- 18 Jun 2023
- 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 18 Jun 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 Glabellar Lines
- ClinicalTrials.gov ID
- NCT04249583
- Acronym / sponsor ID
- READY-1 / 43QM1602
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 5 Jan 2021 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Posted 18 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe GL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: botulinum toxinQM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection |
| Placebo | Placebo comparator | Biological: PlaceboA buffered solution; 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 (3 listed)
- Male or female 18 years of age or older.
- 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) or any botulinum toxin serotype.
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 toxinAlso: QM1114-DPneuromodulator to be injected in the GL region | Biological | Treatment |
| PlaceboPlacebo to be injected in the GL area | Biological | Placebo |
Primary outcome
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.
Time frame: One Month
The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)
1 secondary outcome
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
Time frame: One Month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- 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.
14 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 in people with Glabellar Frown Lines, run by Galderma R&D at 14 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 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 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 18 Jun 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 at One Month. (time frame: One Month). 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 18 Jun 2023.