Treatment of Moderate to Severe Lateral Canthal Lines (READY-2)

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

The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe LCL.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 303
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Dr. Shannon Humphrey, Inc
    • Vancouver, British Columbia, Canada, V6H-4E1
      • Pacific Dermaesthetics, Inc
• United States
  • California
    • Manhattan Beach, California, United States, 90266
      • Ablon Skin Institute and Research Center
    • San Diego, California, United States, 92121
      • Dermatology Cosmetic Laser Medical Associates
    • Solana Beach, California, United States, 92075
      • Art of Skin, MD
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Siperstein Dermatology Group, PLLC
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Facial Plastic Surgicenter, Ltd
  • New York
    • Mount Kisco, New York, United States, 10549
      • The Center for Dermatology, Cosmetic & Laser Surgery
    • Victor, New York, United States, 14564
      • Rochester Dermatologic Surgery, Ltd
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Aesthetic Solutions, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Exclusion Criteria:

1. Previous use of any Botulinum toxin treatment 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) or any botulinum toxin serotype.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; A buffered solution; Mode of administration: intramuscular injection	Biological: Placebo; placebo
Experimental: Treatment; QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection	Biological: botulinum toxin; neuromodulator; Other Names: QM1114-DP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month.	The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)	Month 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.	One Month

Other Outcome Measures

Outcome Measure	Time Frame
Number of subjects who experienced an adverse event	Baseline through Month 6
Number of subjects with abnormal post-baseline QTcF and QTcB intervals	Baseline through Month 6
Number of subjects with binding neutralizing antibodies	Baseline through Month 6

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): September 25, 2020
• Study Completion (Actual): February 10, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Estimated): June 19, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Botulinum Toxins
• Other Study ID Numbers: 43QM1901

Drug and device information, study documents

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