Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination (READY-3)

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

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.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines (GL); Lateral Canthal Lines (LCL)
• Intervention / Treatment: Biological: botulinum toxin neuromodulator; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 413
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Bertucci Medspa, Inc
• United States
  • California
    • Encino, California, United States, 91436
      • Clinical Testing of Beverly Hills
    • Santa Monica, California, United States, 90404
      • AVA MD
    • West Hollywood, California, United States, 90069
      • Skin Care & Laser Physicians of Beverly Hills
  • Florida
    • Aventura, Florida, United States, 33180
      • Center for Clinical and Cosmetic Research
    • Miami, Florida, United States, 33137
      • Baumann Cosmetic & Research Institute, Inc
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Washington Institute of Dermatologic Laser Surgery
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Dermatology, Laser, Skin & Vein Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists, PC
  • New York
    • New York, New York, United States, 10028
      • Lorenc Aesthetic Plastic Surgery Center
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Elite Aesthetic Research
  • Texas
    • Austin, Texas, United States, 78746
      • The Westlake Dermatology Clinical Research

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.
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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QM1114-DP in the LCL + Placebo in the GL; QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection	Biological: botulinum toxin neuromodulator; QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL; Other Names: QM1114-DP; Biological: Placebo; Placebo will be injected into either the LCL, GL, or both the LCL and GL
Placebo Comparator: Placebo in the LCL and GL; A buffered solution; Mode of administration: intramuscular injection	Biological: Placebo; Placebo will be injected into either the LCL, GL, or both the LCL and GL
Experimental: Placebo in the LCL + QM1114-DP in the GL; QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection	Biological: botulinum toxin neuromodulator; QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL; Other Names: QM1114-DP; Biological: Placebo; Placebo will be injected into either the LCL, GL, or both the LCL and GL
Experimental: QM1114-DP in the LCL + GL; QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection	Biological: botulinum toxin neuromodulator; QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL; 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 Glabellar Lines Investigator and Subject Assessments at Maximum Frown	Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown. Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).	Month 1
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile	Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile. Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.	Month 1

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown	Month 1
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.	Month 1

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
Mean change from baseline in vital signs	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): October 2, 2020
• Study Completion (Actual): February 26, 2021

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: June 1, 2023

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: 43QM1902

Drug and device information, study documents

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