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

Medy-Tox415 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

415

Conditions

Glabellar Lines Lateral Canthal Lines

Interventions

MT10109LDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Advanced Research Associates

Glendale, Arizona, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 30

Secondary Outcomes

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)

The investigator evaluates the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe. The outcome is measured as median time to loss of treatment effect (ie, return to moderate or severe GL severity at maximum frown using the FWS).

Time frame: 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)

The percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a ≥2-grade Improvement from Baseline at Maximum Frown at Day 30. The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

Time frame: 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)

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.

Data from ClinicalTrials.gov

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Eye Research Foundation

Newport Beach, California, United States

Skin Research Institute LLC

Coral Gables, Florida, United States

Coleman Center for Cosmetic Dermatologic Surgery

Metairie, Louisiana, United States

MD Laser, Skin, & Vein Institute

Hunt Valley, Maryland, United States

Laser & Skin Surgery Center of New York

New York, New York, United States

Bellaire Dermatology Associates

Bellaire, Texas, United States

SkinDC

Arlington, Virginia, United States

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Dr. Shannon Humphrey Inc.

Vancouver, British Columbia, Canada

...and 11 more locations

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

The outcome was measured Among Participants Who Were Rated At least Mild at Rest at Baseline, where a Responder was Defined as Achieving a ≥1-grade Improvement from Baseline at Day 30 The investigator evaluates the participant's GL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.

Time frame: Day 30

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

This section focuses primarily on Treatment Emergent Adverse Events (TEAEs), i.e., AEs that started or worsened after the first dose of study intervention (Day 1) until up to 30 days after their last visit or study exit. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.

Time frame: 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)

Mean Change From Baseline in Systolic Blood Pressure (BP)

Changes in vital signs: Systolic BP

Time frame: Baseline to Day 360 (Study exit)

Mean Change From Baseline in Diastolic Blood Pressure (BP)

Changes in vital signs: Diastolic BP

Time frame: Baseline to Day 360 (Study exit)

Mean Change From Baseline in Pulse Rate

Changes in vital signs: Pulse Rate

Time frame: Baseline to Day 360 (Study exit)

Mean Change From Baseline in Respiratory Rate

Changes in vital signs: Respiratory Rate

Time frame: Baseline to Day 360 (Study exit)

Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate

Change from baseline for ECG safety population - Heart Rate