Clincosm LogoSign in Get a demo

READY-2: Treatment of Moderate to Severe Lateral Canthal Lines

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT04249687
Collaborator
(none)
303
Enrollment
10
Locations
2
Arms
12
Actual Duration (Months)
30.3
Patients Per Site
2.5
Patients Per Site Per Month

Study Details

Study Description

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 LCL.

Condition or Disease Intervention/Treatment Phase
  • Biological: botulinum toxin
  • Biological: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Feb 10, 2020
Actual Primary Completion Date :
Sep 25, 2020
Actual Study Completion Date :
Feb 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment

QM1114-DP, a Botulinum Toxin Type A (BoNT-A); Mode of administration: intramuscular injection

Biological: botulinum toxin
neuromodulator
Other Names:
  • QM1114-DP

    		•
    Placebo Comparator: Placebo

    A buffered solution; Mode of administration: intramuscular injection

    Biological: Placebo
    placebo

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Month 1]

      The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)

    Secondary Outcome Measures

    1. Percentage of subjects who achieve grade 0 or 1 in Lateral Canthal Line Investigator scale at maximum smile. [Baseline through Month 6]

    Other Outcome Measures

    1. Number of subjects who experienced an adverse event [Baseline through Month 6]

    2. Number of subjects with abnormal post-baseline QTcF and QTcB intervals [Baseline through Month 6]

    3. Number of subjects with binding neutralizing antibodies [Baseline through Month 6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Galderma R&D

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT04249687
    Other Study ID Numbers:
    • 43QM1901
    First Posted:
    Jan 31, 2020
    Last Update Posted:
    May 28, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Botulinum Toxins

    Study Results

    No Results Posted as of May 28, 2021