MT10109L in the Treatment of Glabellar Lines (GL) With or Without Concurrent Treatment of Lateral Canthal Lines (LCL)

Launched by MEDY-TOX · Oct 24, 2018

Keywords

ClinConnect Summary

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Gender

ALL

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.