Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines (READY-4)

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

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).

Study Overview

• Status: Completed
• Conditions: Lateral Canthal Lines; Glabellar Lines
• Intervention / Treatment: Biological: botulinum toxin neuromodulator

• Study Type: Interventional
• Enrollment (Actual): 902
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Jose Raul Montes Eyes & Facial Rejuvenation LLC
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center, PC
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Investigate MD, LLC.
  • California
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research, Inc.
    • Los Angeles, California, United States, 90025
      • Westside Aesthetics
    • Los Angeles, California, United States, 90025
      • Rejuva Medical Aesthetics, LLC
    • Redondo Beach, California, United States, 90277
      • Marcus Facial Plastic Surgery
    • San Francisco, California, United States, 94115
      • The Maas Clinic Research Center
    • Santa Rosa, California, United States, 95401
      • ArteMedica
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin Research, LLC
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Modern Dermatology PC
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical and Cosmetic Research
    • Boca Raton, Florida, United States, 33431
      • Steven Fagien, MD, PA
    • Bradenton, Florida, United States, 34209
      • Susan H. Weinkle, M.D
    • Coral Gables, Florida, United States, 33134
      • Miami Skin and Vein LLC
    • Coral Gables, Florida, United States, 33143
      • Mayoral Dermatology
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute, LLC
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of SouthEast, LLC
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Hamilton Research LLC
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Chicago Cosmetic Surgery and Dermatology, Inc
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Pure Dermatology, LLC
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Skin Laser and Surgery Specialist of NY/NJ
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Elite Aesthetic Research
    • Dublin, Ohio, United States, 43016
      • Aventiv Research, Inc.
  • Texas
    • Dallas, Texas, United States, 75231
      • Dallas Plastic Surgery Institute
    • Dallas, Texas, United States, 75254
      • Center for Advanced Clinical Research
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc.
  • Virginia
    • Arlington, Virginia, United States, 22209
      • SkinDC, PLLC
  • Wisconsin
    • Mequon, Wisconsin, United States, 53092
      • EthiQ2 Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QM1114-DP in the LCL and the GL areas; The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines.	Biological: botulinum toxin neuromodulator; A dose of QM1114-DP will be injected in the GL area and in the LCL area.; Other Names: QM1114-DP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the GL Investigator Scales at Maximum Frown	4-point scale	Week 4
Percentage of Subjects Who Achieve Grade/Level 0 or 1 on the LCL Investigator Scales at Maximum Smile	4-point scale	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who achieve grade/level 0 or 1 on the GL investigator scales at maximum frown	4-point scale	Baseline through 12 months
Percentage of subjects who achieve grade/level 0 or 1 on the LCL investigator scales at maximum smile	4-point scale	Baseline through 12 months
Percentage of subjects who achieve ≥1 grade/level improvement from baseline at each visit using the GL scales at rest	4-point scale	Baseline through 12 months
Percentage of subjects who achieve ≥1 grade/level improvement from baseline at each visit using the LCL scale at relaxed position	4-point scale	Baseline through 12 months

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Actual): April 12, 2021
• Study Completion (Actual): May 21, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 8, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins; Neurotransmitter Agents
• Other Study ID Numbers: 43QM1903

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No