Clinical trial NCT04225260: Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Lateral Canthal Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

- Male or female at least 18 years of age.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown
timeFrame: Week 4
measure: Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center, PC
state: Alabama
city: Scottsdale
country: United States
facility: Investigate MD, LLC.
state: Arizona
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Los Angeles
country: United States
facility: Rejuva Medical Aesthetics, LLC
state: California
city: Los Angeles
country: United States
facility: Westside Aesthetics
state: California
city: Redondo Beach
country: United States
facility: Marcus Facial Plastic Surgery
state: California
city: San Francisco
country: United States
facility: The Maas Clinic Research Center
state: California
city: Santa Rosa
country: United States
facility: ArteMedica
state: California
city: Greenwood Village
country: United States
facility: AboutSkin Research, LLC
state: Colorado
city: Westport
country: United States
facility: Modern Dermatology PC
state: Connecticut
city: Aventura
country: United States
facility: Center for Clinical and Cosmetic Research
state: Florida
city: Boca Raton
country: United States
facility: Steven Fagien, MD, PA
state: Florida
city: Bradenton
country: United States
facility: Susan H. Weinkle, M.D
state: Florida
city: Coral Gables
country: United States
facility: Miami Skin and Vein LLC
state: Florida
city: Coral Gables
country: United States
facility: Mayoral Dermatology
state: Florida
city: Coral Gables
country: United States
facility: Skin Research Institute, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of SouthEast, LLC
state: Florida
city: Alpharetta
country: United States
facility: Hamilton Research LLC
state: Georgia
city: Chicago
country: United States
facility: Chicago Cosmetic Surgery and Dermatology, Inc
state: Illinois
city: Metairie
country: United States
facility: Pure Dermatology, LLC
state: Louisiana
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialist of NY/NJ
state: New Jersey
city: Cincinnati
country: United States
facility: Elite Aesthetic Research
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
city: Dallas
country: United States
facility: Center for Advanced Clinical Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Arlington
country: United States
facility: SkinDC, PLLC
state: Virginia
city: Mequon
country: United States
facility: EthiQ2 Research, LLC
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Jose Raul Montes Eyes & Facial Rejuvenation LLC
Study officials:
References: