Treatment of Moderate to Severe Glabellar Lines (READY-1)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar 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 GL.

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Biological: botulinum toxin; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5R 3N8
      • Sweat Clinics of Canada
• United States
  • California
    • Manhattan Beach, California, United States, 90266
      • \Ablon Skin Institute and Research Center
    • Vista, California, United States, 92083
      • Moradi MD
  • Louisiana
    • New Orleans, Louisiana, United States, 70130
      • Etre Cosmetic Dermatology and Laser Center
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Dermatology, Laser Skin & Vein
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Skin Specialist, PC
  • New York
    • New York, New York, United States, 10021
      • Robert Schwarcz, MD, PC
    • New York, New York, United States, 10021
      • Sachin M Shridharani, MD
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center, PLLC
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
    • Nashville, Tennessee, United States, 37203
      • The Practice of Brian S Biesman, MD
  • Texas
    • Dallas, Texas, United States, 75225
      • Dallas Center for Dermatology & Aesthetics
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research, Inc.
    • Spring, Texas, United States, 77388
      • Integrated Aesthetics, Inc

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 GL at maximum frown as assessed by the Investigator.
3. 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) 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
Experimental: Treatment; QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection	Biological: botulinum toxin; neuromodulator to be injected in the GL region; Other Names: QM1114-DP
Placebo Comparator: Placebo; A buffered solution; Mode of administration: intramuscular injection	Biological: Placebo; Placebo to be injected in the GL area

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 at One Month.	The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)	One Month

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown	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): August 7, 2020
• Study Completion (Actual): January 5, 2021

Study Registration Dates

• First Submitted: December 30, 2019
• 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: September 1, 2022

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: 43QM1602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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