Glabellar Lines Clinical Trial
— READY-4Official 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
| Verified date | July 2020 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 902 |
| Est. completion date | May 21, 2021 |
| Est. primary completion date | April 12, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Jose Raul Montes Eyes & Facial Rejuvenation LLC | San Juan | |
| United States | Hamilton Research LLC | Alpharetta | Georgia |
| United States | SkinDC, PLLC | Arlington | Virginia |
| United States | Center for Clinical and Cosmetic Research | Aventura | Florida |
| United States | Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama |
| United States | Steven Fagien, MD, PA | Boca Raton | Florida |
| United States | Susan H. Weinkle, M.D | Bradenton | Florida |
| United States | SkinCare Physicians | Chestnut Hill | Massachusetts |
| United States | Chicago Cosmetic Surgery and Dermatology, Inc | Chicago | Illinois |
| United States | Elite Aesthetic Research | Cincinnati | Ohio |
| United States | Mayoral Dermatology | Coral Gables | Florida |
| United States | Miami Skin and Vein LLC | Coral Gables | Florida |
| United States | Skin Research Institute, LLC | Coral Gables | Florida |
| United States | Center for Advanced Clinical Research | Dallas | Texas |
| United States | Dallas Plastic Surgery Institute | Dallas | Texas |
| United States | Aventiv Research, Inc. | Dublin | Ohio |
| United States | Center for Dermatology Clinical Research, Inc. | Fremont | California |
| United States | AboutSkin Research, LLC | Greenwood Village | Colorado |
| United States | Skin Laser and Surgery Specialist of NY/NJ | Hackensack | New Jersey |
| United States | Rejuva Medical Aesthetics, LLC | Los Angeles | California |
| United States | Westside Aesthetics | Los Angeles | California |
| United States | EthiQ2 Research, LLC | Mequon | Wisconsin |
| United States | Pure Dermatology, LLC | Metairie | Louisiana |
| United States | Austin Institute for Clinical Research, Inc. | Pflugerville | Texas |
| United States | Marcus Facial Plastic Surgery | Redondo Beach | California |
| United States | The Maas Clinic Research Center | San Francisco | California |
| United States | ArteMedica | Santa Rosa | California |
| United States | Investigate MD, LLC. | Scottsdale | Arizona |
| United States | Research Institute of SouthEast, LLC | West Palm Beach | Florida |
| United States | Modern Dermatology PC | Westport | Connecticut |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown | 4-point scale | Week 4 | |
| Primary | Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile | 4-point scale | Week 4 |
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