MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

NCT03721016 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MT10109L-0052014-005301-21
• Study Type: interventional
• Target: 415
• Locations: 4 countries
• Sites: 21

Brief Summary

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

Conditions

Glabellar Lines; 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)

  The outcome measured is 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 Glabellar Lines (GL) severity at maximum frown at Day 30. The investigator and participant evaluates the participant's GL severity using a Facial Wrinkle Scale With Photonumeric Guide (FWS) at maximum frown on Day 30. The scale ranges from (0 to 3) where 0=none and 3 = severe.

  Day 30

Secondary Outcomes (17)

• The Duration of Glabellar Line (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 Facial Wrinkle Scale (FWS)

  Day 1 (first treatment) to Day 180

• The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)

  Day 30

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

  Day 60

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

  Day 30

• Secondary Safety: Number of Patients Who Experienced an Adverse Event (AE)

  The time frame for AEs is after the first dose (Day 1) and up to 30 days after their last visit or study exit (Day 360 unless participant exits earlier)

Study Arms (3)

MT10109L Dose 1 + Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

MT10109L DRUG

MT10109Lwill be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.

Also known as: NivobotulinumtoxinA

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

Placebo DRUG

Placebo will be injected into either the Glabellar Lines (GL), Lateral Canthal Lines (LCL), or both.

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 (21)

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 Center for Cosmetic Dermatologic Surgery

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

Dr. Shannon Humphrey Inc.

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Project Skin MD

Vancouver, British Columbia, V6H 1K9, Canada

Location

Sweat Clinics of Canada

Toronto, Ontario, M5R 3N8, Canada

Location

Bertucci MedSpa Inc.

Woodbridge, Ontario, L4L 8E2, Canada

Location

Studienzentrum Theatiner46

Munich, Bavaria, 80333, Germany

Location

DRK-Kliniken Nordhessen

Kassel, Hesse, 34121, Germany

Location

Privatpraxis Dr. Hilton & Partner

Düsseldorf, North Rhine-Westphalia, 40212, Germany

Location

RZANY & HUND - Privatpraxis fur Dermatologie und Asthetische Medizin

Berlin, 10707, Germany

Location

Saleh Aesthetic Clinic Ltd.

Cheadle, England, SK8 2BD, United Kingdom

Location

Cranley Clinic

London, England, W1G 7JE, United Kingdom

Location

Bermuda Practice

Basingstoke, Hampshire, RG24 9DT, United Kingdom

Location

Meyer Clinic

Chichester, West Sussex, PO18 8AN, 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: October 24, 2018
• First Posted: October 26, 2018
• Study Start: October 26, 2018
• Primary Completion: March 5, 2020
• Study Completion: January 22, 2021
• Last Updated: May 25, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); DE (4); GB (4); US (9)