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 : Completed
First Posted : January 8, 2019
Last Update Posted : February 9, 2023
- Study Details
- Tabular View
- Results Submitted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Glabellar Lines||Drug: MT10109L Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Completion Date :||January 25, 2021|
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.
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.
Placebo will be injected into the GL.
- 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.
- 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.
- 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
- 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.
- 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.
- Number of patients who experienced an adverse event [ Time Frame: From Consent (Screening Visit) up to Day 420 ]
- Mean change from baseline in vital signs [ Time Frame: Baseline to Day 360 ]
- Mean change from baseline in Electrocardiogram (ECG) parameters [ Time Frame: Baseline to Day 360 ]
- Number of participants with binding and neutralizing antibodies [ Time Frame: Day 360 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
• 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.
- 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.
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
|United States, Arizona|
|Scottsdale, Arizona, United States, 85255|
|United States, California|
|Art of Skin MD|
|Solana Beach, California, United States, 92075|
|United States, Florida|
|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|
|Centre de la Fontaine|
|Loverval, Hainaut, Belgium, 6280|
|Medical Skin Care|
|Sint-Truiden, Limburg, Belgium, 3800|
|Universitair Ziekenhuis Brussel|
|Brussels, Belgium, 1090|
|Liege, Belgium, 4000|
|Kazan State Medical University|
|Kazan, Tatarstan Republic, Russian Federation, 420105|
|Medical Centre Capital-Zdorovie|
|Moscow, Russian Federation, 109369|
|Study Director:||SangMi Park||Medytox Inc.|
|Other Study ID Numbers:||
2018-004384-31 ( EudraCT Number )
|First Posted:||January 8, 2019 Key Record Dates|
|Last Update Posted:||February 9, 2023|
|Last Verified:||January 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|