Trial record 1 of 1 for:
MT10109L-006
MT10109L in the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines
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| ClinicalTrials.gov Identifier: NCT03732833 |
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Recruitment Status :
Completed
First Posted : November 7, 2018
Last Update Posted : September 7, 2022
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Sponsor:
Medy-Tox
Information provided by (Responsible Party):
Medy-Tox
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Brief Summary:
To evaluate the safety and efficacy of MT10109L for the treatment of lateral canthal lines (LCL) with or without concurrent treatment of glabellar lines (GL) in participants with moderate to severe LCL and GL.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lateral Canthal Lines Glabellar Lines | Drug: MT10109L Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 424 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Lateral Canthal Lines With or Without Concurrent Treatment of Glabellar Lines |
| Actual Study Start Date : | November 5, 2018 |
| Actual Primary Completion Date : | March 5, 2020 |
| Actual Study Completion Date : | January 25, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MT10109L Dose 1 + Placebo
MT10109L Dose 1 will be injected into the LCL and Placebo into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
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Drug: MT10109L
MT10109L will be injected into either the LCL, or both the LCL and GL.
Other Name: NivobotulinumtoxinA Drug: Placebo Placebo will be injected into either the GL, or both the LCL and GL. |
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Experimental: MT10109L Dose 1 + MT10109L Dose 2
MT10109L Dose 1 will be injected into the LCL and MT10109L Dose 2 into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
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Drug: MT10109L
MT10109L will be injected into either the LCL, or both the LCL and GL.
Other Name: NivobotulinumtoxinA |
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Placebo Comparator: Placebo
Placebo will be injected into the LCL and into the GL: initial double-blind treatment on Day 1, and up to 2 additional blinded treatments during the retreatment period.
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Drug: Placebo
Placebo will be injected into either the GL, or both the LCL and GL. |
Primary Outcome Measures :
- The proportion 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 LCL severity at maximum smile at Day 30 [ Time Frame: Day 30 ]The investigator and participant evaluate the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Secondary Outcome Measures :
- The duration of 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 FWS [ Time Frame: Day 1 (first treatment) to Day 180 ]The investigator evaluates the participant's LCL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
- The proportion of responders for investigator assessments of LCL severity at maximum smile using the FWS [ Time Frame: Day 30 ]The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
- The proportion of participants reporting mostly satisfied/very satisfied on the Facial Line Satisfaction Questionnaire (FLSQ) follow-up version Item 5 for LCL [ Time Frame: 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.
- The proportion of responders for investigator assessments of LCL severity at rest using the FWS [ Time Frame: Day 30 ]The investigator evaluates the participant's LCL severity using a 4-point scale (0 to 3) where 0=none and 3=severe.
- Number of patients who experienced an adverse event [ Time Frame: From Consent (Screening Visit) up to Day 420 ]
- Mean change from baseline in vital signs [ Time Frame: Baseline to Day 360 ]
- Mean change from baseline in Electrocardiogram (ECG) parameters [ Time Frame: Baseline to Day 360 ]
- Mean change from baseline in lab parameters [ Time Frame: Screening to Day 120 ]
- Number of participants with binding and neutralizing antibodies [ Time Frame: Day 360 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732833
Locations
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Sponsors and Collaborators
Medy-Tox
Investigators
| Study Director: | SangMi Park | Medytox Inc |
| Responsible Party: | Medy-Tox |
| ClinicalTrials.gov Identifier: | NCT03732833 |
| Other Study ID Numbers: |
MT10109L-006 2014-005302-38 ( EudraCT Number ) |
| First Posted: | November 7, 2018 Key Record Dates |
| Last Update Posted: | September 7, 2022 |
| Last Verified: | September 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |