NCT04157686 is a Phase 3 clinical trial of MT10109L Dose 1 in Glabellar Lines, sponsored by Medy-Tox.

Who is sponsoring NCT04157686?

NCT04157686 is sponsored by Medy-Tox.

What drugs are being tested in NCT04157686?

Interventions in NCT04157686: MT10109L Dose 1, MT10109L Dose 2, MT10109L Dose 1 + Dose 2.

What condition does NCT04157686 study?

NCT04157686 studies Glabellar Lines, Lateral Canthal Lines.

Is NCT04157686 still recruiting?

NCT04157686 is currently completed. Last updated 9 August 2024.

Are results published for NCT04157686?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-08-09 · How we verify

NCT04157686

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

MT10109L in the Long-term, Open-label Treatment of Glabellar Lines (GL) and Lateral Canthal Lines (LCL)

Completed Phase 3 Results posted Last updated 9 August 2024

What this trial tests

Phase 3 trial testing MT10109L Dose 1 in Glabellar Lines in 957 participants. Completed in 16 February 2023.

Timeline

23 October 2019

Primary endpoint
16 February 2023

16 February 2023

Quick facts

Lead sponsor	Medy-Tox
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	957
Start date	23 October 2019
Primary completion	16 February 2023
Estimated completion	16 February 2023
Sites	38 locations across Russia, Belgium, United Kingdom, Germany, Canada, United States

Drugs / interventions tested

MT10109L Dose 1
MT10109L Dose 2
MT10109L Dose 1 + Dose 2 — full drug profile →

Conditions studied

Glabellar Lines — all drugs for Glabellar Lines →
Lateral Canthal Lines — all drugs for Lateral Canthal Lines →

Sponsor

Medy-Tox — full company profile →

Who can join

19 and older, any sex, with Glabellar Lines or Lateral Canthal Lines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Experienced Any Adverse Event (AE) Primary · Baseline to Day 720 or Study Exit

The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit.

Group	Value	95% CI
Placebo/MT10109L Dose 1	39
Placebo/MT10109L Dose 2	39
Placebo/MT10109L Dose 1 + Dose 2	80
MT10109L Dose 1/Dose 1	89
MT10109L Dose 2/Dose 2	74
MT10109L Dose 1/Dose 1+2	80
MT10109L Dose 2/Dose 1+2	89
MT10109L Dose 1+2/Dose 1+2	183

Number of Participants Who Experienced Treatment-Related Adverse Events (TEAEs) Primary · Baseline to Day 720 or Study exit

This section focuses primarily on Treatment-Related (Study drug or procedure) Adverse Events(TEAEs). TEAEs are AEs with onset date on or after first dose of study intervention (placebo or MT10109L) in the pivotal study and ≤ 30 days after the study exit visit in the extension study.

Group	Value	95% CI
Placebo/MT10109L Dose 1	18
Placebo/MT10109L Dose 2	4
Placebo/MT10109L Dose 1 + Dose 2	31
MT10109L Dose 1/Dose 1	34
MT10109L Dose 2/Dose 2	11
MT10109L Dose 1/Dose 1+2	22
MT10109L Dose 2/Dose 1+2	42
MT10109L Dose 1+2/Dose 1+2	73

Mean Change From Baseline in Pulse Rate (Beats Per Minute) Primary · Baseline to Day 720 or Study Exit

The outcome reported here is the mean change in pulse rate from baseline to study exit.

Group	Value	95% CI
Placebo/MT10109L Dose 1	3.2	± 15.01
Placebo/MT10109L Dose 2	-2.2	± 13.35
Placebo/MT10109L Dose 1 + Dose 2	-1.2	± 10.95
MT10109L Dose 1/Dose 1	2.0	± 12.77
MT10109L Dose 2/Dose 2	0.6	± 11.58
MT10109L Dose 1/Dose 1+2	0.7	± 10.97
MT10109L Dose 2/Dose 1+2	3.0	± 10.34
MT10109L Dose 1+2/Dose 1+2	1.0	± 8.93

Mean Change From Baseline in Systolic Blood Pressure (mm Hg) Primary · Baseline to Day 720 or Study Exit

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

Group	Value	95% CI
Placebo/MT10109L Dose 1	1.4	± 12.59
Placebo/MT10109L Dose 2	-1.9	± 10.44
Placebo/MT10109L Dose 1 + Dose 2	1.9	± 14.44
MT10109L Dose 1/Dose 1	0.6	± 16.72
MT10109L Dose 2/Dose 2	1.1	± 13.84
MT10109L Dose 1/Dose 1+2	1.8	± 15.24
MT10109L Dose 2/Dose 1+2	1.4	± 14.17
MT10109L Dose 1+2/Dose 1+2	-0.4	± 13.83

Mean Change From Baseline in Diastolic Blood Pressure (mm Hg) Primary · Baseline to Day 720 or Study Exit

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

Group	Value	95% CI
Placebo/MT10109L Dose 1	1.1	± 11.3
Placebo/MT10109L Dose 2	-0.6	± 11.75
Placebo/MT10109L Dose 1 + Dose 2	1.3	± 9.61
MT10109L Dose 1/Dose 1	1.5	± 11.68
MT10109L Dose 2/Dose 2	0.7	± 7.57
MT10109L Dose 1/Dose 1+2	0.0	± 10.62
MT10109L Dose 2/Dose 1+2	2.3	± 9.53
MT10109L Dose 1+2/Dose 1+2	-0.3	± 9.46

Mean Change From Baseline in Respiratory Rate (Breaths Per Minute) Primary · Baseline to Day 720 or Study Exit

The outcome reported here is the mean change in respiratory rate from baseline to study exit.

Group	Value	95% CI
Placebo/MT10109L Dose 1	0.3	± 2.09
Placebo/MT10109L Dose 2	0.6	± 2.15
Placebo/MT10109L Dose 1 + Dose 2	-0.5	± 1.92
MT10109L Dose 1/Dose 1	0.2	± 2.78
MT10109L Dose 2/Dose 2	0.5	± 1.94
MT10109L Dose 1/Dose 1+2	-0.4	± 2.29
MT10109L Dose 2/Dose 1+2	0.4	± 2.21
MT10109L Dose 1+2/Dose 1+2	-0.1	± 2.3

Number of Participants With Binding and Neutralizing Antibodies Primary · Baseline to Day 720 or Study Exit

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.

Group	Value	95% CI
Placebo/MT10109L Dose 1	0
Placebo/MT10109L Dose 2	0
Placebo/MT10109L Dose 1 + Dose 2	0
MT10109L Dose 1/Dose 1	0
MT10109L Dose 2/Dose 2	2
MT10109L Dose 1/Dose 1+2	0
MT10109L Dose 2/Dose 1+2	0
MT10109L Dose 1+2/Dose 1+2	1

Adverse events — posted to ClinicalTrials.gov

Time frame: The safety analyses were conducted in the Intent-to-Treat (ITT) population. All adverse events were collected from the signing of the ICF to 30 days after the participant's last study visit (Day 720/or early exit). Unless otherwise noted, safety results refer to TEAEs.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo/MT10109L Dose 1

Serious: 3/55 (5%)

Deaths: 0/55

Placebo/MT10109L Dose 2

Serious: 1/56 (2%)

Deaths: 0/56

Placebo/MT10109L Dose 1 + Dose 2

Serious: 10/118 (8%)

Deaths: 0/118

MT10109L Dose 1/Dose 1

Serious: 8/116 (7%)

Deaths: 2/116

MT10109L Dose 2/Dose 2

Serious: 9/108 (8%)

Deaths: 0/108

MT10109L Dose 1/Dose 1+2

Serious: 7/128 (5%)

Deaths: 0/128

MT10109L Dose 2/Dose 1+2

Serious: 13/123 (11%)

Deaths: 0/123

MT10109L Dose 1+2/Dose 1+2

Serious: 13/253 (5%)

Deaths: 0/253

Serious adverse events (55 terms)

Reaction	System	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + …	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
COVID-19 pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Allergy to arthropod sting	Immune system disorders	—	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—	—
Diverticulitis	Infections and infestations	—	—	—	—	—	—	—	—
Endometritis	Infections and infestations	—	—	—	—	—	—	—	—
Perirectal abscess	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Subcutaneous abscess	Infections and infestations	—	—	—	—	—	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Face injury	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Intentional overdose	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Road traffic accident	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Obesity	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	Placebo/MT10109L Dose 1	Placebo/MT10109L Dose 2	Placebo/MT10109L Dose 1 + …	MT10109L Dose 1/Dose 1	MT10109L Dose 2/Dose 2	MT10109L Dose 1/Dose 1+2	MT10109L Dose 2/Dose 1+2	MT10109L Dose 1+2/Dose 1+2
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—	—
Injection site bruising	General disorders	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Injection site haemorrhage	General disorders	—	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Procedural Pain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Ligament Sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—

Most-reported serious reactions: Basal cell carcinoma, COVID-19 pneumonia, Syncope, Myocardial infarction, Tachycardia, Conjunctival haemorrhage, Colitis, Cholelithiasis.

Data from ClinicalTrials.gov NCT04157686 adverse events section.

Sponsor's own description

To evaluate the long-term safety of MT10109L in the treatment of GL and/or LCL in participants with moderate to severe GL and/or LCL.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Glabellar Lines

Currently open trials in the same condition.

NCT06205797 — To Evaluate HU-045 in the Treatment of Glabellar Lines(Phase III) · Phase 3 · recruiting

Other Medy-Tox trials

Trials by the same sponsor.

NCT05195112 — Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat · Phase 3 · completed
NCT04281745 — Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX® · Phase 4 · unknown
NCT04144049 — A Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat · Phase 2 · completed
NCT04143854 — Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Lateral Canthal Lines · Phase 2 · completed
NCT04143815 — Clinical Trial to Evaluate the Efficacy and Safety of MBA-P01 in Treatment of Glabellar Lines · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04157686 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medy-Tox
Last refreshed: 9 August 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04157686.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing