Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
- Conditions
- Glabellar LinesLateral Canthal Lines
- Interventions
- Biological: botulinum toxin neuromodulator
- Registration Number
- NCT04225260
- Lead Sponsor
- Galderma R&D
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 902
- Male or female at least 18 years of age.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description QM1114-DP in the LCL and the GL areas botulinum toxin neuromodulator 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.
- Primary Outcome Measures
Name Time Method Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown Week 4 4-point scale
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile Week 4 4-point scale
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Skin Laser and Surgery Specialist of NY/NJ
🇺🇸Hackensack, New Jersey, United States
Center for Clinical and Cosmetic Research
🇺🇸Aventura, Florida, United States
Steven Fagien, MD, PA
🇺🇸Boca Raton, Florida, United States
Research Institute of SouthEast, LLC
🇺🇸West Palm Beach, Florida, United States
Aventiv Research, Inc.
🇺🇸Dublin, Ohio, United States
Center for Advanced Clinical Research
🇺🇸Dallas, Texas, United States
Chicago Cosmetic Surgery and Dermatology, Inc
🇺🇸Chicago, Illinois, United States
Investigate MD, LLC.
🇺🇸Scottsdale, Arizona, United States
Total Skin and Beauty Dermatology Center, PC
🇺🇸Birmingham, Alabama, United States
Elite Aesthetic Research
🇺🇸Cincinnati, Ohio, United States
The Maas Clinic Research Center
🇺🇸San Francisco, California, United States
Rejuva Medical Aesthetics, LLC
🇺🇸Los Angeles, California, United States
Westside Aesthetics
🇺🇸Los Angeles, California, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Marcus Facial Plastic Surgery
🇺🇸Redondo Beach, California, United States
ArteMedica
🇺🇸Santa Rosa, California, United States
AboutSkin Research, LLC
🇺🇸Greenwood Village, Colorado, United States
Modern Dermatology PC
🇺🇸Westport, Connecticut, United States
Susan H. Weinkle, M.D
🇺🇸Bradenton, Florida, United States
Miami Skin and Vein LLC
🇺🇸Coral Gables, Florida, United States
Mayoral Dermatology
🇺🇸Coral Gables, Florida, United States
Skin Research Institute, LLC
🇺🇸Coral Gables, Florida, United States
Hamilton Research LLC
🇺🇸Alpharetta, Georgia, United States
Pure Dermatology, LLC
🇺🇸Metairie, Louisiana, United States
SkinCare Physicians
🇺🇸Chestnut Hill, Massachusetts, United States
Austin Institute for Clinical Research, Inc.
🇺🇸Pflugerville, Texas, United States
Dallas Plastic Surgery Institute
🇺🇸Dallas, Texas, United States
SkinDC, PLLC
🇺🇸Arlington, Virginia, United States
EthiQ2 Research, LLC
🇺🇸Mequon, Wisconsin, United States
Jose Raul Montes Eyes & Facial Rejuvenation LLC
🇵🇷San Juan, Puerto Rico