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
|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|
|Estimated Study Completion Date :||January 31, 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 ]
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|
|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|
|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:||Joan-En Lin||Allergan|