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

Medy-Tox425 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

425

Conditions

Lateral Canthal Lines Glabellar Lines

Interventions

MT10109LDRUG

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

PlaceboDRUG

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

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 (20)

Clear Dermatology & Aesthetics Center

Scottsdale, Arizona, United States

Art of Skin MD

Outcomes

Primary Outcomes

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.

Time frame: Day 30

Secondary Outcomes

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)

The outcome here only considers the INVESTIGATOR assessments (excludes the participant assessment). The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. A Responder was defined as one achieving a ≥2-grade improvement from baseline at maximum smile at Day 30.

Time frame: 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

The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.

Time frame: 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)

Data from ClinicalTrials.gov

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Solana Beach, California, United States

Susan H. Weinkle, MD

Bradenton, Florida, United States

Etre Cosmetic Dermatology and Laser Center

New Orleans, Louisiana, United States

Dermatology and Laser Surgery Center of New York

New York, New York, United States

Skin Search of Rochester Inc.

Rochester, New York, United States

M3 Wake Research Inc.

Raleigh, North Carolina, United States

Wilmington Dermatology Center

Wilmington, North Carolina, United States

Aventiv Research Inc.

Dublin, Ohio, United States

Westlake Dermatology & Cosmetic Surgery - Westlake

Austin, Texas, United States

...and 10 more locations

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.

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

The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe. 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 outcome measured here is the proportion of participants who achieved a ≥1-grade improvement from baseline LCL severity at rest based on investigator FWS rating.

Time frame: Day 30

Number of Patients Who Experienced a Treatment Emergent Adverse Event (TEAEs)

This section focuses primarily on TEAEs, i.e., AEs that started or worsened after the first dose of study intervention and within 30 days after the last dose. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs.

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

Mean Change From Baseline in Systolic Blood Pressure (BP)

The outcome reported here is the mean change in Systolic BP from baseline to study exit.