MT10109L in the Treatment of Glabellar Lines



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:December 24, 2018
End Date:January 1, 2021
Contact:Clinical Trials Registry Team
Email:IR‐CTRegistration@Allergan.com
Phone:877‐277‐8566

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A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of MT10109L (NivobotulinumtoxinA) for the Treatment of Glabellar Lines

To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in
participants with moderate to severe GL.


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
3100 Duraleigh Road
Raleigh, North Carolina 27612
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Austin, TX
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Dublin, Ohio 43016
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New Orleans, Louisiana 70130
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New Orleans, LA
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994 5th Avenue
New York, New York 10028
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New York, NY
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Rochester, New York 14623
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Rochester, NY
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Scottsdale, Arizona 85255
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Scottsdale, AZ
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437 Highway 101
Solana Beach, California 92075
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Solana Beach, CA
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