MT10109L in the Treatment of Lateral Canthal Lines

NCT03785145 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MT10109L-0022014-005279-10
• Study Type: interventional
• Target: 235
• Locations: 3 countries
• Sites: 14

Brief Summary

To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.

Conditions

Lateral Canthal Lines

Outcome Measures

Primary Outcomes (1)

• The Percentage 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 Lateral Canthal Lines (LCL) Severity at Maximum Smile at Day 30

  The primary efficacy measure is a composite endpoint and a participant is considered responder only if both the investigator and participant independently report a ≥ 2-grade improvement at Day 30 of Double-Blind Period from baseline. Both participant and investigator used FWS to assess GL severity. FWS is 4-grade scale (0 to 3): 0=none, 1=mild, 2=moderate and 3=severe

  Day 30

Secondary Outcomes (17)

• The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale (FWS)

  Day 30

• The Duration of Lateral Canthal Lines (LCL) Treatment in Participants Who Achieved a Rating of ≥ 2 Grade Improvement From Baseline in LCL Severity at Maximum Smile at Day 30 According to Investigator Assessments Using the Facial Wrinkle Scale (FWS)

  Day 1 (first treatment) to Day 180

• The Percentage of Participants Reporting Mostly Satisfied/Very Satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) Follow-up Version Item 5 for Lateral Canthal Lines (LCL)

  Day 60

• The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)

  Day 30

• Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration

  AEs that started or worsen after the first dose of study intervention and up to 30 days after their last visit or study exit (Day 360 or early exit)

Study Arms (2)

MT10109L

EXPERIMENTAL

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

Drug: MT10109L

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MT10109L DRUG

MT10109L will be injected into the LCL.

Also known as: NivobotulinumtoxinA

MT10109L

Placebo DRUG

Placebo will be injected into the LCL.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (14)

Advanced Research Associates

Glendale, Arizona, 85308, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Skin Research Institute LLC

Coral Gables, Florida, 33146, United States

Location

Coleman Dermatologic Surgery Center

Metairie, Louisiana, 70006, United States

Location

MD Laser, Skin, & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Laser Skin Surgery Center of New York

New York, New York, 10016, United States

Location

Bellaire Dermatology Associates

Bellaire, Texas, 77401, United States

Location

SkinDC

Arlington, Virginia, 22209, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23502, United States

Location

Moscow scientific-practical centre of dermatovenerology and cosmetology

Moscow, 127473, Russia

Location

State Budget Institution of Higher Education North-Western State Medical University named after I.I Mechnikov

Saint Petersburg, 194291, Russia

Location

Expert Aesthetics Ltd

Alderley Edge, Cheshire, SK9 7ES, United Kingdom

Location

Waverley Medical Practice

Coatbridge, North Lanarkshire, ML5 3AP, United Kingdom

Location

Medizen Clinic

Sutton Coldfield, West Midlands, B74 2UG, United Kingdom

Location

Results Point of Contact

• Title: Young Ryu
• Organization: Medytox Inc.

aab005@medytox.com

+82-2-6901-5424

Study Officials

• SangMi Park

  Medytox Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: December 20, 2018
• Primary Completion: February 27, 2020
• Study Completion: January 25, 2021
• Last Updated: October 5, 2023
• Results First Posted: October 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (2); GB (3); US (9)