MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines

NCT03732833 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MT10109L-0062014-005302-38
• Study Type: interventional
• Target: 425
• Locations: 3 countries
• Sites: 20

Brief Summary

To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.

Conditions

Lateral Canthal Lines; Glabellar 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 LCL Severity at Maximum Smile at Day 30

  The outcome measured is the percentage of participants who had a ≥2-grade improvement from baseline LCL severity at maximum smile according to investigator and participant FWS ratings at Day 30. Both the INVESTIGATOR AND PARTICIPANT evaluate the LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The primary endpoint is achieved and recorded as a count only when BOTH INVESTIGATOR AND PARTICIPANT assess the improvement in FWS from baseline to be ≥ 2-grade improvement. Therefore, the primary endpoint is the proportion/percentage of participants who meet the dual assessment threshold of ≥2-grade improvement from baseline.

  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 With Photonumeric Guide (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 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 a Treatment Emergent Adverse Event (TEAEs)

  AEs that started or worsen after the first dose of study intervention and within 30 days after the last dose.

Study Arms (3)

MT10109L Dose 1 + Placebo

EXPERIMENTAL

MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Drug: MT10109L; Drug: Placebo

MT10109L Dose 1 + MT10109L Dose 2

EXPERIMENTAL

MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Drug: MT10109L

Placebo

PLACEBO COMPARATOR

Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.

Drug: Placebo

Interventions

MT10109L DRUG

MT10109L will be injected into either the LCL, or both the LCL and GL.

Also known as: NivobotulinumtoxinA

MT10109L Dose 1 + MT10109L Dose 2; MT10109L Dose 1 + Placebo

Placebo DRUG

Placebo will be injected into either the GL, or both the LCL and GL.

MT10109L Dose 1 + Placebo; 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 (20)

Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, 85255-4134, United States

Location

Art of Skin MD

Solana Beach, California, 92075-2228, United States

Location

Susan H. Weinkle, MD

Bradenton, Florida, 34209-5642, United States

Location

Etre Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, 70130-4353, United States

Location

Dermatology and Laser Surgery Center of New York

New York, New York, 10028, United States

Location

Skin Search of Rochester Inc.

Rochester, New York, 14623, United States

Location

M3 Wake Research Inc.

Raleigh, North Carolina, 27612-8106, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28403, United States

Location

Aventiv Research Inc.

Dublin, Ohio, 43016, United States

Location

Westlake Dermatology & Cosmetic Surgery - Westlake

Austin, Texas, 78746-4720, United States

Location

DermResearch Inc.

Austin, Texas, 78759, United States

Location

Dr. Jean Carruthers Cosmetic Surgery Inc.

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pacific Derm

Vancouver, British Columbia, V6H 4E1, Canada

Location

Dermetics Cosmetic Dermatology

Burlington, Ontario, L7N 3N2, Canada

Location

Nectar Research Group Inc.

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Rosenpark Research

Darmstadt, Hesse, 64283, Germany

Location

Hautzentrum Koln - Cologne Dermatology

Cologne, 50996, Germany

Location

Hautok and Hautok-cosmetics

München, 80333, Germany

Location

MediCorium Zentrum fuer Dermatologie und Aesthetik

Oberursel, 61440, Germany

Location

CentroDerm GmbH

Wuppertal, 42287, Germany

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: November 5, 2018
• First Posted: November 7, 2018
• Study Start: November 5, 2018
• Primary Completion: March 5, 2020
• Study Completion: January 25, 2021
• Last Updated: July 17, 2023
• Results First Posted: July 17, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); DE (5); CA (4)