MT10109L in the Treatment of Glabellar Lines

• ClinicalTrials.gov Identifier: NCT03795922
• Recruitment Status: Completed
• First Posted: January 8, 2019
• Last Update Posted: February 9, 2023
• Sponsor: Medy-Tox
• Information provided by (Responsible Party): Medy-Tox

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
Glabellar Lines	Drug: MT10109L; Drug: Placebo	Phase 3

Study Design

• 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
• Actual Study Completion Date: January 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 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.

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 [ 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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

Weinkle Dermatology

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

Medy-Tox

Investigators

• Study Director: SangMi Park; Medytox Inc.

More Information

• Responsible Party: Medy-Tox
• ClinicalTrials.gov Identifier: NCT03795922
• Other Study ID Numbers: MT10109L-001; 2018-004384-31 ( EudraCT Number )
• First Posted: January 8, 2019
• 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