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CompletedNCT03795922Updated Jul 27, 2023Results posted

MT10109L in the Treatment of Glabellar Lines

A Phase 3 interventional study of MT10109L and Placebo in Glabellar Lines, sponsored by Medy-Tox. Completed at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

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

Phase
Phase 3
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.

02

Conditions studied

  • Glabellar 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
234 participants (actual)

Study arms

  • Experimental
    MT10109L

    MT10109L will be injected into the GL: 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 GL: initial double-blind treatment on Day 1.

    Drug: Placebo

Interventions

  • DrugMT10109L

    MT10109L will be injected into the GL.

    Also known as: NivobotulinumtoxinA

  • DrugPlacebo

    Placebo will be injected into the GL.

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 Glabellar Lines (GL) Severity at Maximum Frown 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 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

  1. 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 of double-blind period. 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

  2. The Duration of Glabellar Lines (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 (i.e., return to moderate or severe GL severity at maximum frown 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 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.

    Time frame: Day 60

  4. 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 of double-blind period. 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

  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. 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 from the first dose on Day 1 and up to 30 days after their last visit or study exit (Day 360 or early exit).

  6. Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)

    Change from baseline at study exit.

    Time frame: Baseline to Study exit (Day 360 or early exit)

  7. Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)

    Change from baseline at study exit.

    Time frame: Baseline to Study exit (Day 360 or early exit)

  8. Mean Change From Baseline in Vital Signs - Pulse Rate

    Change from baseline at study exit.

    Time frame: Baseline to Study exit (Day 360 or early exit)

  9. Mean Change From Baseline in Vital Signs - Respiratory Rate

    Change from baseline at study exit.

    Time frame: Baseline to Study exit (Day 360 or early exit)

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

    Change from baseline at study exit.

    Time frame: Baseline to Study Exit (Day 360 or early exit)

  11. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval

    Change from baseline at study exit.

    Time frame: Baseline to Study Exit (Day 360 or early exit)

  12. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration

    Change from baseline at study exit.

    Time frame: Baseline to Study Exit (Day 360 or early exit)

  13. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval

    Change from baseline at study exit.

    Time frame: Baseline to Study Exit (Day 360 or early exit)

  14. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval

    Change from baseline at study exit.

    Time frame: Baseline to Study Exit (Day 360 or early exit)

  15. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval

    Change from baseline at study exit.

    Time frame: Baseline to Study Exit (Day 360 or early exit)

  16. Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval

    Change from baseline at study exit.

    Time frame: Baseline to Study Exit (Day 360 or early exit)

  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: Up to Study Exit (Day 360 or early exit)

07

Results

Posted Jun 27, 2023

Participant flow

Participant flow — Overall Study
MilestonePlacebo/MT10109LMT10109L/MT10109L
Started80154
Completed67129
Not completed1325
Withdrew: Adverse event21
Withdrew: Withdrawal by subject513
Withdrew: Lost to follow-up23
Withdrew: Pregnancy01
Withdrew: Physician decision12
Withdrew: Protocol violation01
Withdrew: Other (early termination, covid, family issue)34

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 Glabellar Lines (GL) Severity at Maximum Frown 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 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
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 Glabellar Lines (GL) Severity at Maximum Frown at Day 30
ParticipantsPlacebo/MT10109LMT10109L/MT10109L
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 30071
SecondaryThe 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 of double-blind period. 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
Reported as:
Count of participants · Participants
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)
ParticipantsPlacebo/MT10109LMT10109L/MT10109L
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS)194
SecondaryThe Duration of Glabellar Lines (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 (i.e., return to moderate or severe GL severity at maximum frown using the FWS).

Time frame:
Day 1 (first treatment) to Day 180
Reported as:
Median · Days
The Duration of Glabellar Lines (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)
DaysPlacebo/MT10109LMT10109L/MT10109L
The Duration of Glabellar Lines (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)64 (NA to NA)121 (113 to 145)
SecondaryThe 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.

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 Glabellar Lines (GL)
ParticipantsPlacebo/MT10109LMT10109L/MT10109L
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)7121
SecondaryThe 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 of double-blind period. 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
Reported as:
Count of participants · Participants
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).
ParticipantsPlacebo/MT10109LMT10109L/MT10109L
The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS).2395
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. 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 from the first dose on Day 1 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 Duration35118
SecondaryMean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)

Change from baseline at study exit.

Time frame:
Baseline to Study exit (Day 360 or early exit)
Reported as:
Mean · mmHg
Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)
mmHgPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP)0.3 ± 13.26-0.6 ± 15.28
SecondaryMean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)

Change from baseline at study exit.

Time frame:
Baseline to Study exit (Day 360 or early exit)
Reported as:
Mean · mmHg
Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)
mmHgPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP)0.5 ± 10.04-1.9 ± 10.64
SecondaryMean Change From Baseline in Vital Signs - Pulse Rate

Change from baseline at study exit.

Time frame:
Baseline to Study exit (Day 360 or early exit)
Reported as:
Mean · beats/min
Mean Change From Baseline in Vital Signs - Pulse Rate
beats/minPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Vital Signs - Pulse Rate2.5 ± 10.350.4 ± 10.54
SecondaryMean Change From Baseline in Vital Signs - Respiratory Rate

Change from baseline at study exit.

Time frame:
Baseline to Study exit (Day 360 or early exit)
Reported as:
Mean · breaths/min
Mean Change From Baseline in Vital Signs - Respiratory Rate
breaths/minPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Vital Signs - Respiratory Rate-0.3 ± 2.44-0.3 ± 2.18
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate

Change from baseline at study exit.

Time frame:
Baseline to Study Exit (Day 360 or early exit)
Reported as:
Mean · beats/min
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate
beats/minPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate4.8 ± 10.382.8 ± 8.52
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval

Change from baseline at study exit.

Time frame:
Baseline to Study Exit (Day 360 or early exit)
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval
millisecondsPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval-1.2 ± 11.67-1.2 ± 11.91
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration

Change from baseline at study exit.

Time frame:
Baseline to Study Exit (Day 360 or early exit)
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration
millisecondsPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration0.4 ± 6.651.2 ± 6.41
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval

Change from baseline at study exit.

Time frame:
Baseline to Study Exit (Day 360 or early exit)
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval
millisecondsPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval-11.7 ± 23.87-8.4 ± 19.71
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval

Change from baseline at study exit.

Time frame:
Baseline to Study Exit (Day 360 or early exit)
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval
millisecondsPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval2.7 ± 18.690.0 ± 17.14
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval

Change from baseline at study exit.

Time frame:
Baseline to Study Exit (Day 360 or early exit)
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval
millisecondsPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval-2.4 ± 15.43-2.9 ± 14.06
SecondaryMean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval

Change from baseline at study exit.

Time frame:
Baseline to Study Exit (Day 360 or early exit)
Reported as:
Mean · milliseconds
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval
millisecondsPlacebo/MT10109LMT10109L/MT10109L
Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval-64.6 ± 127.1-39.3 ± 106.19
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:
Up to Study Exit (Day 360 or early exit)
Reported as:
Count of participants · Participants
Number of Participants With Binding and Neutralizing Antibodies
ParticipantsPlacebo/MT10109LMT10109L/MT10109L
Number of Participants With Binding and Neutralizing Antibodies10

Adverse events

Collected over The time frame for AEs is 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
Placebo0/80 (0%)3/80 (3.8%)8/80 (10%)
MT10109L0/223 (0%)5/223 (2.2%)32/223 (14.3%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventPlaceboMT10109L
PneumoniaInfections and infestations1/800/223
Radius fractureInjury, poisoning and procedural complications1/800/223
Road traffic accidentInjury, poisoning and procedural complications1/800/223
Intentional OverdoseInjury, poisoning and procedural complications1/800/223
COVID-19 pneumoniaInfections and infestations0/801/223
Rectal prolapseGastrointestinal disorders0/801/223
FallInjury, poisoning and procedural complications0/801/223
Hip fractureInjury, poisoning and procedural complications0/801/223
Breast CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/801/223
Breast Cancer Stage IINeoplasms benign, malignant and unspecified (incl cysts and polyps)0/801/223
Most frequent other events
Most frequent other events
EventPlaceboMT10109L
HeadacheNervous system disorders4/8022/223
Injection site painGeneral disorders4/8016/223

Baseline characteristics

234 participants were included in the Intent To Treat (ITT) population (80 participants in the placebo group and 154 participants in the MT10109L group).

Age, Categorical
Age, Categorical(Participants)Placebo/MT10109LMT10109L/MT10109LTotal
<=18 years000
Between 18 and 65 years77141218
>=65 years31316
Age, Continuous
Age, Continuous(years)Placebo/MT10109LMT10109L/MT10109LTotal
Mean46.4 ± 11.5747.3 ± 12.6447.0 ± 12.27
Sex: Female, Male
Sex: Female, Male(Participants)Placebo/MT10109LMT10109L/MT10109LTotal
Female76140216
Male41418
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo/MT10109LMT10109L/MT10109LTotal
Hispanic or Latino31013
Not Hispanic or Latino77144221
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo/MT10109LMT10109L/MT10109LTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American268
White76146222
More than one race112
Unknown or Not Reported000
08

Study locations

15 sites
  • Investigate MD
    Scottsdale, Arizona 85255, United States
  • Art of Skin MD
    Solana Beach, California 92075, United States
  • Weinkle Dermatology
    Bradenton, Florida 34209, United States
  • Etre, Cosmetic Dermatology and Laser Center
    New Orleans, Louisiana 70130, United States
  • Dermatology and Laser Surgery Center of New York
    New York, New York 10028, United States
  • SkinSearch of Rochester, Inc.
    Rochester, New York 14623, United States
  • M3 Wake Research, Inc.
    Raleigh, North Carolina 27612, United States
  • Aventiv Research, Inc.
    Dublin, Ohio 43016, United States
  • Westlake Dermatology & Cosmetic Surgery
    Austin, Texas 78746, United States
  • Centre de la Fontaine
    Loverval, Hainaut 6280, Belgium
  • Medical Skin Care
    Sint-Truiden, Limburg 3800, Belgium
  • Universitair Ziekenhuis Brussel
    Brussels, 1090, Belgium
  • CHU Liege
    Liege, 4000, Belgium
  • Kazan State Medical University
    Kazan, Tatarstan Republic 420105, Russian Federation
  • Medical Centre Capital-Zdorovie
    Moscow, 109369, Russian Federation
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 Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03795922
Lead sponsor
Medy-Tox
Responsible party
Sponsor
First posted
Jan 8, 2019
Start date
Dec 24, 2018
Primary completion
Mar 13, 2020
Completion
Jan 25, 2021
Results posted
Jun 27, 2023
Last update
Jul 27, 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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