Clinical trial NCT04247074: Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines (GL)
Lateral Canthal Lines (LCL)
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-01-29
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age or older.
2. Moderate to severe LCL at maximum smile as assessed by the Investigator.
3. Moderate to severe LCL at maximum smile as assessed by the subject.
4. Moderate to severe GL at maximum frown as assessed by the Investigator.
5. Moderate to severe GL at maximum frown as assessed by the subject

Exclusion Criteria:

1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
2. Female who is pregnant, breast feeding, or intends to conceive a child during the study.
3. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP).

Primary outcomes:
measure: Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown
timeFrame: Month 1
measure: Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile
timeFrame: Month 1
Secondary outcomes:
measure: Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
timeFrame: Month 1
measure: Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.
timeFrame: Month 1
Other outcomes:
Locations:
city: Encino
country: United States
facility: Clinical Testing of Beverly Hills
state: California
city: Santa Monica
country: United States
facility: Ava MD
state: California
city: West Hollywood
country: United States
facility: Skin Care & Laser Physicians of Beverly Hills
state: California
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic & Research Institute, Inc
state: Florida
city: Chevy Chase
country: United States
facility: Washington Institute of Dermatologic Laser Surgery
state: Maryland
city: Hunt Valley
country: United States
facility: Maryland Dermatology, Laser, Skin & Vein Institute
state: Maryland
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: New York
country: United States
facility: Lorenc Aesthetic Plastic Surgery Center
state: New York
city: Cincinnati
country: United States
facility: Elite Aesthetic Research
state: Ohio
city: Austin
country: United States
facility: The Westlake Dermatology Clinical Research
state: Texas
city: Woodbridge
country: Canada
facility: Bertucci Medspa, Inc
state: Ontario
Study officials:
References: