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

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT04247074
Collaborator
(none)
411
Enrollment
12
Locations
4
Arms
12.6
Actual Duration (Months)
34.3
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
411 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 and Glabellar Lines Alone or in Combination
Actual Study Start Date :
Feb 10, 2020
Actual Primary Completion Date :
Oct 2, 2020
Actual Study Completion Date :
Feb 26, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    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 [Month 1]

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

    2. 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 with a 0 or 1 on the Glabellar Lines Investigator scale at maximum frown [Baseline through Month 6]

    2. 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. Mean change from baseline in vital signs [Baseline through Month 6]

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

    4. 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.

    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Testing of Beverly Hills Encino California United States 91436
    2 Ava MD Santa Monica California United States 90404
    3 Skin Care & Laser Physicians of Beverly Hills West Hollywood California United States 90069
    4 Center for Clinical and Cosmetic Research Aventura Florida United States 33180
    5 Baumann Cosmetic & Research Institute, Inc Miami Florida United States 33137
    6 Washington Institute of Dermatologic Laser Surgery Chevy Chase Maryland United States 20815
    7 Maryland Dermatology, Laser, Skin & Vein Institute Hunt Valley Maryland United States 21030
    8 Skin Specialists, PC Omaha Nebraska United States 68144
    9 Lorenc Aesthetic Plastic Surgery Center New York New York United States 10028
    10 Elite Aesthetic Research Cincinnati Ohio United States 45236
    11 The Westlake Dermatology Clinical Research Austin Texas United States 78746
    12 Bertucci Medspa, Inc Woodbridge Ontario Canada L4L 8E2

    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:
    NCT04247074
    Other Study ID Numbers:
    • 43QM1902
    First Posted:
    Jan 29, 2020
    Last Update Posted:
    May 28, 2021
    Last Verified:
    May 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
    Neurotransmitter Agents

    Study Results

    No Results Posted as of May 28, 2021