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READY-4: Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT04225260
Collaborator
(none)
902
Enrollment
30
Locations
1
Arm
15.8
Actual Duration (Months)
30.1
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).

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

Study Design

Study Type:
Interventional
Actual Enrollment :
902 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Study to Evaluate the Safety of QM1114-DP for the Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines
Actual Study Start Date :
Jan 27, 2020
Actual Primary Completion Date :
Apr 12, 2021
Actual Study Completion Date :
May 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: QM1114-DP in the LCL and the GL areas

The investigational product (QM1114-DP) is a BoNT Type A. At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines.

Biological: botulinum toxin neuromodulator
A dose of QM1114-DP will be injected in the GL area and in the LCL area.
Other Names:
  • QM1114-DP

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of subjects who experienced a Treatment Emergent AEs (TEAEs) [Baseline through 12 months]

    Secondary Outcome Measures

    1. Percentage of subjects who achieve grade/level 0 or 1 on the GL investigator scales at maximum frown [Baseline through 12 months]

      4-point scale

    2. Percentage of subjects who achieve grade/level 0 or 1 on the LCL investigator scales at maximum smile [Baseline through 12 months]

      4-point scale

    3. Percentage of subjects who achieve ≥1 grade/level improvement from baseline at each visit using the GL scales at rest [Baseline through 12 months]

      4-point scale

    4. Percentage of subjects who achieve ≥1 grade/level improvement from baseline at each visit using the LCL scale at relaxed position [Baseline through 12 months]

      4-point scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Male or female at least 18 years of age.
    Exclusion Criteria:

    • Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.

    • Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Total Skin and Beauty Dermatology Center, PC Birmingham Alabama United States 35205
    2 Investigate MD, LLC. Scottsdale Arizona United States 85255
    3 Center for Dermatology Clinical Research, Inc. Fremont California United States 94538
    4 Rejuva Medical Aesthetics, LLC Los Angeles California United States 90025
    5 Westside Aesthetics Los Angeles California United States 90025
    6 Marcus Facial Plastic Surgery Redondo Beach California United States 90277
    7 The Maas Clinic Research Center San Francisco California United States 94115
    8 ArteMedica Santa Rosa California United States 95401
    9 AboutSkin Research, LLC Greenwood Village Colorado United States 80111
    10 Modern Dermatology PC Westport Connecticut United States 06880
    11 Center for Clinical and Cosmetic Research Aventura Florida United States 33180
    12 Steven Fagien, MD, PA Boca Raton Florida United States 33431
    13 Susan H. Weinkle, M.D Bradenton Florida United States 34209
    14 Miami Skin and Vein LLC Coral Gables Florida United States 33134
    15 Mayoral Dermatology Coral Gables Florida United States 33143
    16 Skin Research Institute, LLC Coral Gables Florida United States 33146
    17 Research Institute of SouthEast, LLC West Palm Beach Florida United States 33401
    18 Hamilton Research LLC Alpharetta Georgia United States 30022
    19 Chicago Cosmetic Surgery and Dermatology, Inc Chicago Illinois United States 60654
    20 Pure Dermatology, LLC Metairie Louisiana United States 70001
    21 SkinCare Physicians Chestnut Hill Massachusetts United States 02467
    22 Skin Laser and Surgery Specialist of NY/NJ Hackensack New Jersey United States 07601
    23 Elite Aesthetic Research Cincinnati Ohio United States 45236
    24 Aventiv Research, Inc. Dublin Ohio United States 43016
    25 Dallas Plastic Surgery Institute Dallas Texas United States 75231
    26 Center for Advanced Clinical Research Dallas Texas United States 75254
    27 Austin Institute for Clinical Research, Inc. Pflugerville Texas United States 78660
    28 SkinDC, PLLC Arlington Virginia United States 22209
    29 EthiQ2 Research, LLC Mequon Wisconsin United States 53092
    30 Jose Raul Montes Eyes & Facial Rejuvenation LLC San Juan Puerto Rico 00917

    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:
    NCT04225260
    Other Study ID Numbers:
    • 43QM1903
    First Posted:
    Jan 13, 2020
    Last Update Posted:
    May 28, 2021
    Last Verified:
    Jul 1, 2020
    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