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
1 other identifier
interventional
300
2 countries
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2020
Shorter than P25 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 30, 2019
CompletedFirst Posted
Study publicly available on registry
January 31, 2020
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2021
CompletedResults Posted
Study results publicly available
June 18, 2023
CompletedJune 18, 2023
September 1, 2022
6 months
December 30, 2019
May 23, 2023
May 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown
One Month
Study Arms (2)
Treatment
EXPERIMENTALQM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
Placebo
PLACEBO COMPARATORA buffered solution; Mode of administration: intramuscular injection
Interventions
neuromodulator to be injected in the GL region
Eligibility Criteria
You may qualify if:
- Male or female 18 years of age or older.
- Moderate to severe GL at maximum frown as assessed by the Investigator.
- Moderate to severe GL at maximum frown as assessed by the subject.
You may not qualify if:
- Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (14)
\Ablon Skin Institute and Research Center
Manhattan Beach, California, 90266, United States
Moradi MD
Vista, California, 92083, United States
Etre Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130, United States
Maryland Dermatology, Laser Skin & Vein
Hunt Valley, Maryland, 21030, United States
Skin Specialist, PC
Omaha, Nebraska, 68144, United States
Robert Schwarcz, MD, PC
New York, New York, 10021, United States
Sachin M Shridharani, MD
New York, New York, 10021, United States
Wilmington Dermatology Center, PLLC
Wilmington, North Carolina, 28405, United States
The Practice of Brian S Biesman, MD
Nashville, Tennessee, 37203, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
Dallas Center for Dermatology & Aesthetics
Dallas, Texas, 75225, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
Integrated Aesthetics, Inc
Spring, Texas, 77388, United States
Sweat Clinics of Canada
Toronto, Ontario, M5R 3N8, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Galderma Research & Development
- Organization
- Galderma Research & Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 30, 2019
First Posted
January 31, 2020
Study Start
February 10, 2020
Primary Completion
August 7, 2020
Study Completion
January 5, 2021
Last Updated
June 18, 2023
Results First Posted
June 18, 2023
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share