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MT10109L in the Treatment of Glabellar Lines

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT03795922
Collaborator
(none)
234
Enrollment
15
Locations
2
Arms
25.1
Actual Duration (Months)
15.6
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines
Actual Study Start Date :
Dec 24, 2018
Actual Primary Completion Date :
Mar 13, 2020
Actual Study Completion Date :
Jan 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: MT10109L

MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.

Drug: MT10109L
MT10109L will be injected into the GL.
Other Names:
  • NivobotulinumtoxinA

    		•
    Placebo Comparator: Placebo

    Placebo will be injected into the GL: initial double-blind treatment on Day 1.

    Drug: Placebo
    Placebo will be injected into the GL.

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of participants with a ≥ 2-grade improvement from baseline on the Facial Wrinkle Scale With Photonumeric Guide (FWS) according to investigator and participant assessments of GL severity at maximum frown at Day 30 [Day 30]

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

    Secondary Outcome Measures

    1. The duration of GL treatment in participants who achieved a rating of ≥ 2-grade improvement from baseline in GL severity at maximum frown at Day 30 according to investigator assessments using the FWS [Day 1 (first treatment) to Day 180]

      The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

    2. The proportion of responders for investigator assessments of GL severity at maximum frown using the FWS [Day 30]

      The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe

    3. The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for GL [Day 60]

      The Satisfaction Question 5 grades facial line treatment satisfaction on a 5-point scale (-2 to 2) where -2=Very dissatisfied and 2=Very satisfied.

    4. The proportion of responders for investigator assessments of GL severity at rest using the FWS [Day 30]

      The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

    5. Number of patients who experienced an adverse event [From Consent (Screening Visit) up to Day 420]

    6. Mean change from baseline in vital signs [Baseline to Day 360]

    7. Mean change from baseline in Electrocardiogram (ECG) parameters [Baseline to Day 360]

    8. Number of participants with binding and neutralizing antibodies [Day 360]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria

    • Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

    Exclusion Criteria

    • Known immunization or hypersensitivity to any botulinum toxin serotype.

    • Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.

    • History of facial nerve palsy.

    • Any uncontrolled systemic disease.

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

    • Anticipated need for surgery or overnight hospitalization during the study.

    • Prior exposure to botulinum toxin of any serotype for any reason.

    • Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

    • Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.

    • Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

    • Females who are pregnant, nursing, or planning a pregnancy during the study.

    • Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigate MD Scottsdale Arizona United States 85255
    2 Art of Skin MD Solana Beach California United States 92075
    3 Susan H. Weinkle, MD Bradenton Florida United States 34209
    4 Etre, Cosmetic Dermatology and Laser Center New Orleans Louisiana United States 70130
    5 Dermatology and Laser Surgery Center of New York New York New York United States 10028
    6 SkinSearch of Rochester, Inc. Rochester New York United States 14623
    7 M3 Wake Research, Inc. Raleigh North Carolina United States 27612
    8 Aventiv Research, Inc. Dublin Ohio United States 43016
    9 Westlake Dermatology & Cosmetic Surgery Austin Texas United States 78746
    10 Centre de la Fontaine Loverval Hainaut Belgium 6280
    11 Medical Skin Care Sint-Truiden Limburg Belgium 3800
    12 Universitair Ziekenhuis Brussel Brussels Belgium 1090
    13 CHU Liege Liege Belgium 4000
    14 Kazan State Medical University Kazan Tatarstan Republic Russian Federation 420105
    15 Medical Centre Capital-Zdorovie Moscow Russian Federation 109369

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Joan-En Lin, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT03795922
    Other Study ID Numbers:
    • MT10109L-001
    • 2018-004384-31
    First Posted:
    Jan 8, 2019
    Last Update Posted:
    Mar 5, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Mar 5, 2021