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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005279-10 | EudraCT Number |
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To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT10109L | Experimental | MT10109L will be injected into the LCL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. |
|
| Placebo | Placebo Comparator | Placebo will be injected into the LCL: initial double-blind treatment on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT10109L | Drug | MT10109L will be injected into the LCL. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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| Name | Affiliation | Role |
|---|---|---|
| SangMi Park | Medytox Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Associates | Glendale | Arizona | 85308 | United States | ||
| Eye Research Foundation |
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235 met the inclusion/exclusion criteria and were randomized. 234 participants entered the study and were treated.
This note is to explain why the number of participants to start a Period is not equal to the number who completed previous Period: Only participants who met the retreatment criteria received additional treatments (up to 2 times) in open label period. Therefore, the total number of treatments was different for each participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo During Double-blind/MT10109L During Open-label | Placebo was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1. Double-blind portion: Placebo was injected into the LCL. Open-label portion: In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L injections |
| FG001 | MT10109L During Double-blind/MT10109L During Open-label | MT10109L was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. Double-blind portion: MT10109L was injected into the LCL. Open-label portion: Participants who met retreatment criteria were allowed up to 2 additional MT10109L injections |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 - Double Blind (Days 1-180) |
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| |||||||||||||||||||||
| Cycle 2 - Open Label Treatment 1 |
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| Cycle 3 - Open Label Treatment 2 |
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235 participants were included in the Intent To Treat (ITT) population (77 participants in the placebo group and 158 participants in theMT10109L group).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1. Placebo: Placebo was injected into the LCL. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L |
| BG001 | MT10109L |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | All primary and secondary efficacy analyses endpoints were carried out using the Intent-To-Treat (ITT) analysis set, which was defined as all participants who were randomized. Multiple imputation method was used for missing variables in primary efficacy endpoint. Analyses of the secondary efficacy variables were performed using observed data. | Posted | Count of Participants | Participants | Day 30 |
|
The time frame for the treatment-emergent adverse events(TEAEs) was from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit)
All safety analyses were carried out using the Safety population, defined as participants who received at least 1dose of study intervention. Participants were grouped based on their actual treatment received and not planned treatment. TEAE's experienced by the participants in the placebo group during the open-label part (MT10109L Cycles 2 and 3) were counted in MT10109L group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1. Placebo: Placebo was injected into the LCL. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA, Version 23.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Young Ryu | Medytox Inc. | +82-2-6901-5424 | aab005@medytox.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 30, 2020 | Jun 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 18, 2020 | Jun 2, 2023 | SAP_001.pdf |
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| Placebo | Drug | Placebo will be injected into the LCL. |
|
| 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). | 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) | 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. | Day 60 |
| 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. | 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. | 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. | Baseline to Day 360 |
| Mean Change From Baseline in Diastolic Blood Pressure (BP) | The outcome reported here is the mean change in Diastolic BP from baseline to study exit. | Baseline to Day 360 |
| Mean Change From Baseline in Pulse Rate | The outcome reported here is the mean change in Pulse Rate from baseline to study exit. | Baseline to Day 360 |
| Mean Change From Baseline in Respiratory Rate | The outcome reported here is the mean change in Respiratory Rate from baseline to study exit. | Baseline to Day 360 |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate | The outcome reported here is a mean change in mean heart rate from baseline to studyexit | Baseline to Day 360 |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | The outcome reported here is a mean change in PR Interval from baseline to study exit | Baseline to Day 360 |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | The outcome reported here is a mean change in QRS duration from baseline to study exit | Baseline to Day 360 |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | The outcome reported here is a mean change in QT Interval from baseline to study exit | Baseline to Day 360 |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | The outcome reported here is a mean change in QTcB Interval from baseline to study exit | Baseline to Day 360 |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | The outcome reported here is a mean change in QTcF Interval from baseline to study exit | Baseline to Day 360 |
| Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | The outcome reported here is a mean change in RR Interval from baseline to study exit | Baseline to Day 360 |
| Number of Participants With Binding and Neutralizing Antibodies | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | Baseline to Day 360 |
| Newport Beach |
| California |
| 92663 |
| United States |
| Skin Research Institute LLC | Coral Gables | Florida | 33146 | United States |
| Coleman Dermatologic Surgery Center | Metairie | Louisiana | 70006 | United States |
| MD Laser, Skin, & Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| Laser Skin Surgery Center of New York | New York | New York | 10016 | United States |
| Bellaire Dermatology Associates | Bellaire | Texas | 77401 | United States |
| SkinDC | Arlington | Virginia | 22209 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Moscow scientific-practical centre of dermatovenerology and cosmetology | Moscow | 127473 | Russia |
| State Budget Institution of Higher Education North-Western State Medical University named after I.I Mechnikov | Saint Petersburg | 194291 | Russia |
| Expert Aesthetics Ltd | Alderley Edge | Cheshire | SK9 7ES | United Kingdom |
| Waverley Medical Practice | Coatbridge | North Lanarkshire | ML5 3AP | United Kingdom |
| Medizen Clinic | Sutton Coldfield | West Midlands | B74 2UG | United Kingdom |
| Lost to Follow-up |
|
| Death |
|
| 1 participant was randomized to the placebo group but was not treated. This is counted in 'Other '. |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
MT10109L was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. MT10109L: MT10109L was injected into the LCL. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Placebo |
Placebo was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1. Placebo: Placebo was injected into the LCL. In the open-label part, participants who met retreatment criteria were allowed up to 2 MT10109L |
| OG001 | MT10109L | MT10109L was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. MT10109L: MT10109L was injected into the LCL. |
|
|
| Secondary | 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. | All secondary efficacy analyses endpoints were carried out using the Intent-To-Treat (ITT) analysis subset at day 30, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Secondary | 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). | The analysis population for this outcome includes the 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). This corresponds to the responders for Outcome 2. Note: Analyses of the secondary efficacy variables were performed using observed data. | Posted | Median | 95% Confidence Interval | Days | Day 1 (first treatment) to Day 180 |
|
|
|
| Secondary | 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) | 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. | All secondary efficacy analyses endpoints were carried out using the Intent-To-Treat (ITT) analysis subset at day 60, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. | Posted | Count of Participants | Participants | Day 60 |
|
|
|
| Secondary | 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. | This secondary efficacy analysis was carried out using the Intent-To-Treat (ITT) analysis subset at day 30, which was defined as all participants who were randomized. Analyses of the secondary efficacy variables were performed using observed data. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Secondary | 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. | All safety analyses were carried out using the Safety population set defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. Please note: Participants in placebo group who entered open-label phase (post Day 180) and received study intervention (MT10109L) are counted in MT10109L group. Thus, overall number of participants in MT10109L group is greater than what is noted in participants flow. | Posted | Count of Participants | Participants | 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) |
|
|
|
| Secondary | 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. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Diastolic Blood Pressure (BP) | The outcome reported here is the mean change in Diastolic BP from baseline to study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | mmHg | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Pulse Rate | The outcome reported here is the mean change in Pulse Rate from baseline to study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | beats/min | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Respiratory Rate | The outcome reported here is the mean change in Respiratory Rate from baseline to study exit. | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | breaths/min | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate | The outcome reported here is a mean change in mean heart rate from baseline to studyexit | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | beats/min | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval | The outcome reported here is a mean change in PR Interval from baseline to study exit | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration | The outcome reported here is a mean change in QRS duration from baseline to study exit | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval | The outcome reported here is a mean change in QT Interval from baseline to study exit | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval | The outcome reported here is a mean change in QTcB Interval from baseline to study exit | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval | The outcome reported here is a mean change in QTcF Interval from baseline to study exit | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Day 360 |
|
|
|
| Secondary | Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval | The outcome reported here is a mean change in RR Interval from baseline to study exit | All safety analyses were carried out using the Safety population subset at study exit, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. In order to calculate the mean change from baseline, participants with non-missing analysis values at both baseline and post-baseline during that analysis visit were used. | Posted | Mean | Standard Deviation | milliseconds | Baseline to Day 360 |
|
|
|
| Secondary | Number of Participants With Binding and Neutralizing Antibodies | Only samples that tested positive in the binding antibody confirmatory assay were evaluated for neutralizing antibodies. The participants with positive neutralizing antibodies are only shown. | The immunogenicity was analyzed in Safety population, defined as participants who received at least 1 dose of study intervention. Participants were grouped based on their actual treatment received. | Posted | Count of Participants | Participants | Baseline to Day 360 |
|
|
|
| 0 |
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | MT10109L | MT10109L was injected into the Lateral Canthal Lines (LCL): initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period. MT10109L: MT10109L was injected into the LCL. | 1 | 223 | 7 | 223 | 0 | 223 |
| COVID-19 | Infections and infestations | MedDRA, Version 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA, Version 23.1 | Systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | MedDRA, Version 23.1 | Systematic Assessment |
|
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA, Version 23.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA, Version 23.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA, Version 23.1 | Systematic Assessment |
|
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 23.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA, Version 23.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 23.1 | Systematic Assessment |
|
General research agreement between the sponsor and PI's that includes a confidentiality section with a statement that the sponsor is and shall remain the exclusive owner of 'Information'. 'Information' shall include, but shall not be limited to, protocols, trade secrets, know-how, formulations, inventions, techniques, equipment, data and results.