MT10109L in the Treatment of Lateral Canthal Lines
Status: | Recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | December 20, 2018 |
End Date: | January 9, 2021 |
Contact: | Clinical Trials Registry Team |
Email: | IR‐CTRegistration@Allergan.com |
Phone: | 877‐277‐8566 |
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
To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines
(LCL) in participants with moderate to severe LCL
(LCL) in participants with moderate to severe LCL
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.
We found this trial at
8
sites
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