Clinical trial NCT03908008: Efficacy and Safety Study of MT10107 in the Treatment of Glabella Line
Official title: A Parallel, Active Drug Controlled, Double Blind, Randomized, Multi-center, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10107 Versus BOTOX® in Treatment of Glabella Line
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Frown Lines
Keywords: Glabella line
Glabella lines
Botulinum Toxin
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line.

Detailed description: This study design is a parallel, active drug controlled, double blind, randomized, multi-centered, phase III clinical trial to compare the efficacy and safety of MT10107 versus BOTOX® in treatment of glabella line. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a total of 20U (4U/0.1ml each) in five sites of the glabella line. Thereafter, follow-up visits will be made at 4 weeks, 10 weeks, 16 weeks and the efficacy and safety assessments will be conducted for a total of 16 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
* Men and women aged between 20 and 65
* Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
* Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

* Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
* Patients who have bleeding tendency or taking anti-coagulant
* Patients suffering from acute diseases
* Patients who have been injected with botulinum toxin within past 3 months before the injection
* Patients with allergy or hypersensitivity to the investigational products or their components
* Patients who are pregnant or lactating or found to be pregnant through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period
* Patients who have been given any of the following drugs within previous 4 weeks at screening: Muscle relaxants, benzodiazepine, aminoglycoside antibiotics, other antibiotics, and anticholinergic drugs.
* Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
* Patients with skin damage or infection at the injection site.
* Patients who scheduled a double eyelid operation during the clinical trial.
* Patients who have received or have a plan to receive other procedures, which may affect glabella and forehead lines within 6 months
* Patients whose glabella lines cannot be spread apart even with physical methods like using hands.
* Patients who are participating in other clinical trials or have participated in other clinical trials within 30 days of the screening date.
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study at the discretion of the investigator

Primary outcomes:
measure: Investigator's live assessment of glabella line improvement rate
timeFrame: 4 weeks after the injection
Secondary outcomes:
measure: Investigator's live assessment of glabella line improvement rate
timeFrame: 10, 16 weeks after the injection
measure: Investigator's live assessment of glabella line improvement rate
timeFrame: 4, 10, 16 weeks after the injection
measure: Investigator's photographic assessment of glabella line improvement rate at maximum frown
timeFrame: 4 weeks after the injection
measure: Investigator's photographic assessment of glabella line improvement rate at rest
timeFrame: 4 weeks after the injection
measure: Subject's satisfaction questionnaire to assess treatment efficacy
timeFrame: 4, 10, 16 weeks after the injection
measure: Glabella line improvement rate of subject's assessment
timeFrame: 4, 10, 16 weeks after the injection
measure: The number of participants with adverse events determined by MedDra ver 17.0 for assessment of safety in IP
timeFrame: Through study completion, approximately 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Huh Changhun, M.D.
role: STUDY_CHAIR
affiliation: Konkuk University Hospital
name: Yangwon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jonghee Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: