Treatment of Moderate to Severe Lateral Canthal Lines
- Conditions
- Lateral Canthal Lines
- Registration Number
- NCT04249687
- Lead Sponsor
- Galderma R&D
- Brief 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 LCL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
- 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.
- Previous use of any Botulinum toxin treatment 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month. Month 1 The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile. One Month
Trial Locations
- Locations (10)
Ablon Skin Institute and Research Center
🇺🇸Manhattan Beach, California, United States
Dermatology Cosmetic Laser Medical Associates
🇺🇸San Diego, California, United States
Art of Skin, MD
🇺🇸Solana Beach, California, United States
Siperstein Dermatology Group, PLLC
🇺🇸Boynton Beach, Florida, United States
Facial Plastic Surgicenter, Ltd
🇺🇸Baltimore, Maryland, United States
The Center for Dermatology, Cosmetic & Laser Surgery
🇺🇸Mount Kisco, New York, United States
Rochester Dermatologic Surgery, Ltd
🇺🇸Victor, New York, United States
Aesthetic Solutions, PA
🇺🇸Chapel Hill, North Carolina, United States
Dr. Shannon Humphrey, Inc
🇨🇦Vancouver, British Columbia, Canada
Pacific Dermaesthetics, Inc
🇨🇦Vancouver, British Columbia, Canada
Ablon Skin Institute and Research Center🇺🇸Manhattan Beach, California, United States