Status:
COMPLETED
MT10109L in the Treatment of Lateral Canthal Lines
Lead Sponsor:
Medy-Tox
Conditions:
Lateral Canthal Lines
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2021
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT03785145
Start Date
December 20 2018
End Date
January 25 2021
Last Update
October 5 2023
Active Locations (14)
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1
Advanced Research Associates
Glendale, Arizona, United States, 85308
2
Eye Research Foundation
Newport Beach, California, United States, 92663
3
Skin Research Institute LLC
Coral Gables, Florida, United States, 33146
4
Coleman Dermatologic Surgery Center
Metairie, Louisiana, United States, 70006