MT10109L in the Treatment of Glabellar Lines

NCT03795922 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MT10109L-0012018-004384-31
• Study Type: interventional
• Target: 234
• Locations: 3 countries
• Sites: 15

Brief Summary

To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.

Conditions

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 Glabellar Lines (GL) Severity at Maximum Frown 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 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 Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)

  Day 30

• The Duration of Glabellar Lines (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 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

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

  The time frame for AEs is from the first dose on Day 1 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 GL: 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 GL: initial double-blind treatment on Day 1.

Drug: Placebo

Interventions

MT10109L DRUG

MT10109L will be injected into the GL.

Also known as: NivobotulinumtoxinA

MT10109L

Placebo DRUG

Placebo will be injected into the GL.

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 (15)

Investigate MD

Scottsdale, Arizona, 85255, United States

Location

Art of Skin MD

Solana Beach, California, 92075, United States

Location

Weinkle Dermatology

Bradenton, Florida, 34209, United States

Location

Etre, Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, 70130, United States

Location

Dermatology and Laser Surgery Center of New York

New York, New York, 10028, United States

Location

SkinSearch of Rochester, Inc.

Rochester, New York, 14623, United States

Location

M3 Wake Research, Inc.

Raleigh, North Carolina, 27612, United States

Location

Aventiv Research, Inc.

Dublin, Ohio, 43016, United States

Location

Westlake Dermatology & Cosmetic Surgery

Austin, Texas, 78746, United States

Location

Centre de la Fontaine

Loverval, Hainaut, 6280, Belgium

Location

Medical Skin Care

Sint-Truiden, Limburg, 3800, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

CHU Liege

Liège, 4000, Belgium

Location

Kazan State Medical University

Kazan', Tatarstan Republic, 420105, Russia

Location

Medical Centre Capital-Zdorovie

Moscow, 109369, Russia

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: January 8, 2019
• Study Start: December 24, 2018
• Primary Completion: March 13, 2020
• Study Completion: January 25, 2021
• Last Updated: July 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (9); RU (2); BE (4)