Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
READY-4
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
1 other identifier
interventional
902
2 countries
30
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2020
Shorter than P25 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedStudy Start
First participant enrolled
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 21, 2021
CompletedResults Posted
Study results publicly available
June 18, 2023
CompletedJune 18, 2023
July 1, 2020
1.2 years
January 7, 2020
May 23, 2023
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
4-point scale
Week 4
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
4-point scale
Week 4
Study Arms (1)
QM1114-DP in the LCL and the GL areas
EXPERIMENTALThe 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.
Interventions
A dose of QM1114-DP will be injected in the GL area and in the LCL area.
Eligibility Criteria
You may qualify if:
- \- Male or female at least 18 years of age.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (30)
Total Skin and Beauty Dermatology Center, PC
Birmingham, Alabama, 35205, United States
Investigate MD, LLC.
Scottsdale, Arizona, 85255, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Rejuva Medical Aesthetics, LLC
Los Angeles, California, 90025, United States
Westside Aesthetics
Los Angeles, California, 90025, United States
Marcus Facial Plastic Surgery
Redondo Beach, California, 90277, United States
The Maas Clinic Research Center
San Francisco, California, 94115, United States
ArteMedica
Santa Rosa, California, 95401, United States
AboutSkin Research, LLC
Greenwood Village, Colorado, 80111, United States
Modern Dermatology PC
Westport, Connecticut, 06880, United States
Center for Clinical and Cosmetic Research
Aventura, Florida, 33180, United States
Steven Fagien, MD, PA
Boca Raton, Florida, 33431, United States
Susan H. Weinkle, M.D
Bradenton, Florida, 34209, United States
Miami Skin and Vein LLC
Coral Gables, Florida, 33134, United States
Mayoral Dermatology
Coral Gables, Florida, 33143, United States
Skin Research Institute, LLC
Coral Gables, Florida, 33146, United States
Research Institute of SouthEast, LLC
West Palm Beach, Florida, 33401, United States
Hamilton Research LLC
Alpharetta, Georgia, 30022, United States
Chicago Cosmetic Surgery and Dermatology, Inc
Chicago, Illinois, 60654, United States
Pure Dermatology, LLC
Metairie, Louisiana, 70001, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467, United States
Skin Laser and Surgery Specialist of NY/NJ
Hackensack, New Jersey, 07601, United States
Elite Aesthetic Research
Cincinnati, Ohio, 45236, United States
Aventiv Research, Inc.
Dublin, Ohio, 43016, United States
Dallas Plastic Surgery Institute
Dallas, Texas, 75231, United States
Center for Advanced Clinical Research
Dallas, Texas, 75254, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
SkinDC, PLLC
Arlington, Virginia, 22209, United States
EthiQ2 Research, LLC
Mequon, Wisconsin, 53092, United States
Jose Raul Montes Eyes & Facial Rejuvenation LLC
San Juan, 00917, Puerto Rico
Results Point of Contact
- Title
- Galderma Research & Development
- Organization
- Galderma Research & Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2020
First Posted
January 13, 2020
Study Start
January 27, 2020
Primary Completion
April 12, 2021
Study Completion
May 21, 2021
Last Updated
June 18, 2023
Results First Posted
June 18, 2023
Record last verified: 2020-07