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MT10109L in the Treatment of Glabellar Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03795922
Recruitment Status : Active, not recruiting
First Posted : January 8, 2019
Last Update Posted : April 6, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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
Glabellar Lines Drug: MT10109L Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : December 24, 2018
Actual Primary Completion Date : March 13, 2020
Estimated Study Completion Date : January 31, 2021

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 Name: 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.




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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From Consent (Screening Visit) up to Day 420 ]
  6. Mean change from baseline in vital signs [ Time Frame: Baseline to Day 360 ]
  7. Mean change from baseline in Electrocardiogram (ECG) parameters [ Time Frame: Baseline to Day 360 ]
  8. Number of participants with binding and neutralizing antibodies [ Time Frame: Day 360 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795922


Locations
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United States, Arizona
Investigate MD
Scottsdale, Arizona, United States, 85255
United States, California
Art of Skin MD
Solana Beach, California, United States, 92075
United States, Florida
Susan H. Weinkle, MD
Bradenton, Florida, United States, 34209
United States, Louisiana
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, United States, 70130
United States, New York
Dermatology and Laser Surgery Center of New York
New York, New York, United States, 10028
SkinSearch of Rochester, Inc.
Rochester, New York, United States, 14623
United States, North Carolina
M3 Wake Research, Inc.
Raleigh, North Carolina, United States, 27612
United States, Ohio
Aventiv Research, Inc.
Dublin, Ohio, United States, 43016
United States, Texas
Westlake Dermatology & Cosmetic Surgery
Austin, Texas, United States, 78746
Belgium
Centre de la Fontaine
Loverval, Hainaut, Belgium, 6280
Medical Skin Care
Sint-Truiden, Limburg, Belgium, 3800
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
CHU Liege
Liege, Belgium, 4000
Russian Federation
Kazan State Medical University
Kazan, Tatarstan Republic, Russian Federation, 420105
Medical Centre Capital-Zdorovie
Moscow, Russian Federation, 109369
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joan-En Lin Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03795922    
Other Study ID Numbers: MT10109L-001
2018-004384-31 ( EudraCT Number )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No