MT10109L in the Treatment of Glabellar Lines

Medytox

Status and phase: Completed; Phase 3

Conditions: Glabellar Lines

Treatments: Drug: Placebo; Drug: MT10109L

Study type: Interventional

Funder types: Industry

Identifiers

NCT03795922

2018-004384-31 (EudraCT Number)

MT10109L-001

Details and patient eligibility

About

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

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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234 participants in 2 patient groups, including a placebo group

MT10109L

Experimental group

Description:

MT10109L will be injected into the GL: initial double-blind treatment on Day 1, and up to 2 open-label study interventions during the retreatment period.

Treatment:

Drug: MT10109L

Placebo

Placebo Comparator group

Description:

Placebo will be injected into the GL: initial double-blind treatment on Day 1.

Treatment:

Drug: Placebo