NCT03795922 is a Phase 3 clinical trial of MT10109L in Glabellar Lines, sponsored by Medy-Tox.

Who is sponsoring NCT03795922?

NCT03795922 is sponsored by Medy-Tox.

What drugs are being tested in NCT03795922?

Interventions in NCT03795922: MT10109L, Placebo.

What condition does NCT03795922 study?

NCT03795922 studies Glabellar Lines.

Is NCT03795922 still recruiting?

NCT03795922 is currently completed. Last updated 27 July 2023.

Are results published for NCT03795922?

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

Last reviewed 2023-07-27 · How we verify

NCT03795922

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

MT10109L in the Treatment of Glabellar Lines

Completed Phase 3 Results posted Last updated 27 July 2023

What this trial tests

Phase 3 trial testing MT10109L in Glabellar Lines in 234 participants. Completed in 25 January 2021.

Timeline

24 December 2018

Primary endpoint
13 March 2020

25 January 2021

Quick facts

Lead sponsor	Medy-Tox
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	234
Start date	24 December 2018
Primary completion	13 March 2020
Estimated completion	25 January 2021
Sites	15 locations across Belgium, Russia, United States

Drugs / interventions tested

MT10109L — full drug profile →
Placebo

Conditions studied

Glabellar Lines — all drugs for Glabellar Lines →

Sponsor

Medy-Tox — full company profile →

Who can join

18 and older, any sex, with Glabellar 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.

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 Primary · 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 participa

Group	Value	95% CI
Placebo/MT10109L	0
MT10109L/MT10109L	71

The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) Secondary · Day 30

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

Group	Value	95% CI
Placebo/MT10109L	1
MT10109L/MT10109L	94

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) Secondary · Day 1 (first treatment) to Day 180

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).

Group	Value	95% CI
Placebo/MT10109L	64	NA – NA
MT10109L/MT10109L	121	113 – 145

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) Secondary · Day 60

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.

Group	Value	95% CI
Placebo/MT10109L	7
MT10109L/MT10109L	121

The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). Secondary · Day 30

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.

Group	Value	95% CI
Placebo/MT10109L	23
MT10109L/MT10109L	95

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

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.

Group	Value	95% CI
Placebo	35
MT10109L	118

Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP) Secondary · Baseline to Study exit (Day 360 or early exit)