MT10109L in the Treatment of Lateral Canthal Lines

Medy-Tox235 enrolled

Overview

To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

235

Conditions

Lateral Canthal Lines

Interventions

MT10109LDRUG

MT10109L will be injected into the LCL.

PlaceboDRUG

Placebo will be injected into the LCL.

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 (14)

Advanced Research Associates

Glendale, Arizona, United States

Eye Research Foundation

Newport Beach, California, 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) According to INVESTIGATOR AND PARTICIPANT Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile 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, 1=mild, 2=moderate and 3=severe

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 (FWS)

The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale (FWS), where a Responder was defined as Achieving a≥2-grade Improvement from Baseline at Maximum Smile at Day 30. The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none, 1=mild, 2=moderate and 3=severe.

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 Facial Wrinkle Scale (FWS)

The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none, 1=mild, 2=moderate and 3 = severe using the Facial Wrinkle Scale (FWS). The outcome is measured as median time to loss of treatment effect (i.e., return to moderate or severe LCL severity at maximum smile using the FWS).

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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Skin Research Institute LLC

Coral Gables, Florida, United States

Coleman Dermatologic Surgery Center

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

Moscow scientific-practical centre of dermatovenerology and cosmetology

Moscow, Russia

...and 4 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, 1=mild, 2=moderate and 3=severe. The outcome was measured among participants who were at least mild at rest at baseline, where a responder was defined as achieving a \>=1-grade improvement from baseline at Day 30.

Time frame: Day 30

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

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. TEAE's are recorded by the PI and their study team from observations made after treatment administration. The safety analyses were conducted in the Safety population. Unless otherwise noted, safety results refer to TEAEs. All safety analyses were performed with participants analyzed by their actual treatment or regimen received.

Time frame: AEs that started or worsen after the first dose of study intervention and up to 30 days after their last visit or study exit (Day 360 or early exit)

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.