This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
413
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
Placebo will be injected into either the LCL, GL, or both the LCL and GL
Clinical Testing of Beverly Hills
Encino, California, United States
Ava MD
Santa Monica, California, United States
Skin Care & Laser Physicians of Beverly Hills
West Hollywood, California, United States
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown
Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown. Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).
Time frame: Month 1
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile
Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile. Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.
Time frame: Month 1
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
Time frame: Month 1
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.
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Center for Clinical and Cosmetic Research
Aventura, Florida, United States
Baumann Cosmetic & Research Institute, Inc
Miami, Florida, United States
Washington Institute of Dermatologic Laser Surgery
Chevy Chase, Maryland, United States
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Lorenc Aesthetic Plastic Surgery Center
New York, New York, United States
Elite Aesthetic Research
Cincinnati, Ohio, United States
...and 2 more locations
Time frame: Month 1