Phase 3
N=234
MT10109L in the Treatment of Glabellar Lines
Glabellar Lines
Bottom Line
View on ClinicalTrials.gov: NCT03795922 ↗Enrolled (actual)
234
Serious AEs
2.6%
Results posted
Jun 2023
Primary outcome: 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 Glabellar Lines (GL) Severity at Maximum Frown at Day 30 — 0; 71 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MT10109L (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medy-Tox
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 Glabellar Lines (GL) Severity at Maximum Frown at Day 30 |
0; 71 | — |
| SECONDARY The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Maximum Frown Using the Facial Wrinkle Scale (FWS) |
1; 94 | — |
| SECONDARY 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; 121 | — |
| SECONDARY 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) |
7; 121 | — |
| SECONDARY The Percentage of Responders for Investigator Assessments of Glabellar Lines (GL) Severity at Rest Using the Facial Wrinkle Scale (FWS). |
23; 95 | — |
| SECONDARY Number of Patients Who Experienced an Adverse Event (AE) Through the Study Duration |
35; 118 | — |
| SECONDARY Mean Change From Baseline in Vital Signs - Systolic Blood Pressure (BP) |
0.3; -0.6 | — |
| SECONDARY Mean Change From Baseline in Vital Signs - Diastolic Blood Pressure (BP) |
0.5; -1.9 | — |
| SECONDARY Mean Change From Baseline in Vital Signs - Pulse Rate |
2.5; 0.4 | — |
| SECONDARY Mean Change From Baseline in Vital Signs - Respiratory Rate |
-0.3; -0.3 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) Parameters - Heart Rate |
4.8; 2.8 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) Parameters - PR Interval |
-1.2; -1.2 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QRS Duration |
0.4; 1.2 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QT Interval |
-11.7; -8.4 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcB Interval |
2.7; 0.0 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) Parameters - QTcF Interval |
-2.4; -2.9 | — |
| SECONDARY Mean Change From Baseline in Electrocardiogram (ECG) Parameters - RR Interval |
-64.6; -39.3 | — |
| SECONDARY Number of Participants With Binding and Neutralizing Antibodies |
1; 0 | — |
Summary
To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in participants with moderate to severe GL.
Eligibility Criteria
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
- Known immunization or hypersensitivity 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 investigational 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.
Data sourced from ClinicalTrials.gov (NCT03795922). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.