Glabellar LinesPhase 3READY-4NCT04225260

Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

A Phase 3 study testing botulinum toxin neuromodulator in people with Glabellar Lines and Lateral Canthal Lines, run by Galderma R&D at 30 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL). Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Glabellar Lines, Lateral Canthal Lines
What is being tested?: botulinum toxin neuromodulator
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 902 participants
Where: 30 sitesin 2 countries
Study dates: 27 Jan 2020to 21 May 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 at least 18 years of age.

Who cannot join

Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
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

30 sites in 2 countries.

Country

City, postcode or hospital

30 sites in 2 countries

United States29 sites

Hamilton Research LLC
Alpharetta, Georgia, 30022
SkinDC, PLLC
Arlington, Virginia, 22209
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205
Steven Fagien, MD, PA
Boca Raton, Florida, 33431
Susan H. Weinkle, M.D
Bradenton, Florida, 34209
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Chicago Cosmetic Surgery and Dermatology, Inc
Chicago, Illinois, 60654
Elite Aesthetic Research
Cincinnati, Ohio, 45236
Miami Skin and Vein LLC
Coral Gables, Florida, 33134
Mayoral Dermatology
Coral Gables, Florida, 33143
Skin Research Institute, LLC
Coral Gables, Florida, 33146
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Center for Advanced Clinical Research
Dallas, Texas, 75254
Aventiv Research, Inc.
Dublin, Ohio, 43016
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111
Skin Laser and Surgery Specialist of NY/NJ
Hackensack, New Jersey, 07601
Rejuva Medical Aesthetics, LLC
Los Angeles, California, 90025
Westside Aesthetics
Los Angeles, California, 90025
EthiQ2 Research, LLC
Mequon, Wisconsin, 53092
Pure Dermatology, LLC
Metairie, Louisiana, 70001
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
Marcus Facial Plastic Surgery
Redondo Beach, California, 90277
The Maas Clinic Research Center
San Francisco, California, 94115
ArteMedica
Santa Rosa, California, 95401
Investigate MD, LLC.
Scottsdale, Arizona, 85255
Research Institute of SouthEast, LLC
West Palm Beach, Florida, 33401
Modern Dermatology PC
Westport, Connecticut, 06880

Other trials in United States

Puerto Rico1 site

Jose Raul Montes Eyes & Facial Rejuvenation LLC
San Juan, 00917

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Open-Label Study to Evaluate the Safety of QM1114-DP for the Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

Conditions: Glabellar Lines, Lateral Canthal Lines
Being tested: botulinum toxin neuromodulator

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
A dose of QM1114-DP will be injected in the GL area and in the LCL area.

Study groups in NCT04225260
Study group	Role	What they receive
QM1114-DP in the LCL and the GL areas	Experimental	The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines. 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 Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
4-point scale
Measured: Week 4
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
4-point scale
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 202021 May 2021

First posted13 Jan 2020
Study start27 Jan 2020
Primary completion12 Apr 2021
Study completion21 May 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 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
Masking: None (open label)
Enrolment: 902 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04225260
Sponsor's protocol ID: 43QM1903
Acronym: READY-4
Status last verified: Jul 2020
First submitted: 7 Jan 2020
Last updated: 18 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
Active, not recruitingPhase 1
A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines

All Glabellar Lines trials

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, Open-Label Study to Evaluate the Safety of QM1114-DP for the Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
ClinicalTrials.gov ID: NCT04225260
Acronym / sponsor ID: READY-4 / 43QM1903
Conditions: Glabellar Lines, Lateral Canthal Lines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 902 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 27 Jan 2020 (actual)
Primary completion: 12 Apr 2021 (actual)
Study completion: 21 May 2021 (actual)
First posted: 13 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
QM1114-DP in the LCL and the GL areas	Experimental	Biological: botulinum toxin neuromodulatorThe investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male or female at least 18 years of age.

Key exclusion criteria (4 listed)

Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
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 toxin neuromodulatorAlso: QM1114-DPA dose of QM1114-DP will be injected in the GL area and in the LCL area.	Biological	QM1114-DP in the LCL and the GL areas

Primary outcome

Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
Time frame: Week 4
4-point scale
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
Time frame: Week 4
4-point scale

Results and safety

Results posted to the registry on 18 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QM1114-DP in the LCL and the GL Areas	902	790

Primary outcome: Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown

Time frame: Week 4. Count of participants. Unit: Participants

Measure	QM1114-DP in the GL n = 847
Value	769

Population analysed: FAS

Primary outcome: Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile

Time frame: Week 4. Count of participants. Unit: Participants

Measure	QM1114-DP in the LCL n = 847
Value	719

Adverse events

Time frame: 12 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QM1114-DP in the LCL and the GL Areas	23 of 902 (2.5%)	243 of 902 (26.9%)	1 of 902

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.

Related trials for Glabellar Lines

RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
Active, not recruitingPhase 1
A Study to Evaluate Sequential Administration of Injections of AGN-151586 Followed by BOTOX in Adult Participants for Treatment of Glabellar Lines
Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines

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.

30 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 Lines and Lateral Canthal Lines, run by Galderma R&D at 30 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 1 inclusion and 4 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 30 sites in United States, Puerto Rico. 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 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 Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown (time frame: Week 4). 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?

On the ClinicalTrials.gov record for NCT04225260.

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.