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CompletedNCT03785145Updated Oct 5, 2023Results posted

MT10109L in the Treatment of Lateral Canthal Lines

A Phase 3 interventional study of MT10109L and Placebo in Lateral Canthal Lines, sponsored by Medy-Tox. Completed at 14 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-05.

Sponsored by Medy-Tox · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
235
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Lateral Canthal Lines
03

In context

Lead sponsor

Medy-Tox is the lead sponsor of 49 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.

Browse Medy-Tox studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria

  • Known immunization or 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 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
235 participants (actual)

Study arms

  • Experimental
    MT10109L

    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.

    Drug: MT10109L

  • Placebo comparator
    Placebo

    Placebo will be injected into the LCL: initial double-blind treatment on Day 1.

    Drug: Placebo

Interventions

  • DrugMT10109L

    MT10109L will be injected into the LCL.

    Also known as: NivobotulinumtoxinA

  • DrugPlacebo

    Placebo will be injected into the LCL.

06

What researchers measure

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 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

  1. 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

  2. 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

  3. 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.

    Time frame: Day 60

  4. 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

  5. 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)

  6. 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.

    Time frame: Baseline to Day 360

  7. 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.

    Time frame: Baseline to Day 360

  8. Mean Change From Baseline in Pulse Rate

    The outcome reported here is the mean change in Pulse Rate from baseline to study exit.

    Time frame: Baseline to Day 360

  9. Mean Change From Baseline in Respiratory Rate

    The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.

    Time frame: Baseline to Day 360

  10. 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

    Time frame: Baseline to Day 360

  11. 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

    Time frame: Baseline to Day 360

  12. 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

    Time frame: Baseline to Day 360

  13. 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

    Time frame: Baseline to Day 360

  14. 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

    Time frame: Baseline to Day 360

  15. 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

    Time frame: Baseline to Day 360

  16. 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

    Time frame: Baseline to Day 360

  17. 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.

    Time frame: Baseline to Day 360

07

Results

Posted Oct 5, 2023

Participant flow

Cycle 1 - Double Blind (Days 1-180)
Participant flow — Cycle 1 - Double Blind (Days 1-180)
MilestonePlacebo During Double-blind/MT10109L During Open-labelMT10109L During Double-blind/MT10109L During Open-label
Started77158
Completed68145
Not completed913
Withdrew: Adverse event01
Withdrew: Withdrawal by subject69
Withdrew: Lost to follow-up22
Withdrew: Death01
Withdrew: 1 participant was randomized to the placebo group but was not treated. this is counted in 'other '.10
Cycle 2 - Open Label Treatment 1
Participant flow — Cycle 2 - Open Label Treatment 1
MilestonePlacebo During Double-blind/MT10109L During Open-labelMT10109L During Double-blind/MT10109L During Open-label
Started65144
Completed61130
Not completed414
Withdrew: Withdrawal by subject15
Withdrew: Lost to follow-up16
Withdrew: Covid-19; enrolled in a different study23
Cycle 3 - Open Label Treatment 2
Participant flow — Cycle 3 - Open Label Treatment 2
MilestonePlacebo During Double-blind/MT10109L During Open-labelMT10109L During Double-blind/MT10109L During Open-label
Started4991
Completed4988
Not completed03
Withdrew: Withdrawal by subject01
Withdrew: Lost to follow-up01
Withdrew: Covid-19, enrolled in a different study01

Outcome measures

PrimaryThe 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
Reported as:
Count of participants · Participants
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
ParticipantsPlaceboMT10109L
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 30248
SecondaryThe 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
Reported as:
Count of participants · Participants
The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale (FWS)
ParticipantsPlaceboMT10109L
The Percentage of Responders for INVESTIGATOR Assessments of Lateral Canthal Lines (LCL) Severity at Maximum Smile Using the Facial Wrinkle Scale (FWS)357
SecondaryThe 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
Reported as:
Median · Days
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)
DaysPlaceboMT10109L
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)242 (NA to NA)148 (114.0 to 158)
SecondaryThe 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.

Time frame:
Day 60
Reported as:
Count of participants · Participants
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)
ParticipantsPlaceboMT10109L
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)4107
SecondaryThe 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
Reported as:
Count of participants · Participants
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)
ParticipantsPlaceboMT10109L
The Percentage of Responders for Investigator Assessments of Lateral Canthal Lines (LCL) Severity at Rest Using the Facial Wrinkle Scale (FWS)1175
SecondaryNumber 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)
Reported as:
Count of participants · Participants
Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration
ParticipantsPlaceboMT10109L
Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration1278
SecondaryMean Change From Baseline in Systolic Blood Pressure (BP)

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

Time frame:
Baseline to Day 360
Reported as:
Mean · mmHg
Mean Change From Baseline in Systolic Blood Pressure (BP)
mmHgPlaceboMT10109L
Mean Change From Baseline in Systolic Blood Pressure (BP)1.8 ± 12.280.5 ± 11.83
SecondaryMean Change From Baseline in Diastolic Blood Pressure (BP)

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

Time frame:
Baseline to Day 360
Reported as:
Mean · mmHg
Mean Change From Baseline in Diastolic Blood Pressure (BP)
mmHgPlaceboMT10109L
Mean Change From Baseline in Diastolic Blood Pressure (BP)0.4 ± 9.730.3 ± 9.42
SecondaryMean Change From Baseline in Pulse Rate

The outcome reported here is the mean change in Pulse Rate from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · beats/min
Mean Change From Baseline in Pulse Rate
beats/minPlaceboMT10109L
Mean Change From Baseline in Pulse Rate-2.0 ± 13.13-0.8 ± 11.38
SecondaryMean Change From Baseline in Respiratory Rate

The outcome reported here is the mean change in Respiratory Rate from baseline to study exit.

Time frame:
Baseline to Day 360
Reported as:
Mean · breaths/min
Mean Change From Baseline in Respiratory Rate
breaths/minPlaceboMT10109L
Mean Change From Baseline in Respiratory Rate0.7 ± 2.34-0.1 ± 1.89
SecondaryMean 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

Time frame:
Baseline to Day 360
Reported as:
Mean · beats/min
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
beats/minPlaceboMT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate2.9 ± 10.154.9 ± 10.36
SecondaryMean 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

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
millisecondsPlaceboMT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval-2.1 ± 12.76-0.7 ± 13.65
SecondaryMean 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

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
millisecondsPlaceboMT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration2.6 ± 9.170.8 ± 7.14
SecondaryMean 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

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
millisecondsPlaceboMT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval-3.9 ± 22.08-11.3 ± 23.92
SecondaryMean 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

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
millisecondsPlaceboMT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval3.7 ± 18.421.8 ± 20.3
SecondaryMean 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

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
millisecondsPlaceboMT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval1.0 ± 14.97-2.9 ± 16.79
SecondaryMean 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

Time frame:
Baseline to Day 360
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
millisecondsPlaceboMT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval-32.2 ± 122.66-58.2 ± 127.37
SecondaryNumber 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.

Time frame:
Baseline to Day 360
Reported as:
Count of participants · Participants
Number of Participants With Binding and Neutralizing Antibodies
ParticipantsPlaceboMT10109L
Number of Participants With Binding and Neutralizing Antibodies02

Adverse events

Collected over 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). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/76 (0%)0/76 (0%)0/76 (0%)
MT10109L1/223 (0.4%)7/223 (3.1%)0/223 (0%)
Most frequent serious events
Most frequent serious events
EventPlaceboMT10109L
DeathGeneral disorders0/761/223
COVID-19Infections and infestations0/761/223
PneumoniaInfections and infestations0/761/223
Suspected COVID-19Infections and infestations0/761/223
Alcohol poisoningInjury, poisoning and procedural complications0/761/223
ArthritisMusculoskeletal and connective tissue disorders0/761/223
ExostosisMusculoskeletal and connective tissue disorders0/761/223
Malignant melanoma in situNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/761/223
Squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/761/223
Respiratory distressRespiratory, thoracic and mediastinal disorders0/761/223

Baseline characteristics

235 participants were included in the Intent To Treat (ITT) population (77 participants in the placebo group and 158 participants in theMT10109L group).

Age, Categorical
Age, Categorical(Participants)PlaceboMT10109LTotal
<=18 years000
Between 18 and 65 years75149224
>=65 years2911
Age, Continuous
Age, Continuous(Years)PlaceboMT10109LTotal
Mean46.1 ± 11.0946.6 ± 11.4346.4 ± 11.3
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboMT10109LTotal
Female61127188
Male163147
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboMT10109LTotal
Hispanic or Latino103343
Not Hispanic or Latino67125192
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboMT10109LTotal
American Indian or Alaska Native022
Asian178
Native Hawaiian or Other Pacific Islander000
Black or African American235
White74145219
More than one race000
Unknown or Not Reported011
08

Study locations

14 sites
  • Advanced Research Associates
    Glendale, Arizona 85308, United States
  • Eye Research Foundation
    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, Russian Federation
  • State Budget Institution of Higher Education North-Western State Medical University named after I.I Mechnikov
    Saint-Petersburg, 194291, Russian Federation
  • 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
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03785145
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Dec 24, 2018
Start date
Dec 20, 2018
Primary completion
Feb 27, 2020
Completion
Jan 25, 2021
Results posted
Oct 5, 2023
Last update
Oct 5, 2023

Study contacts

SangMi Park
study director · Medytox Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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