Clinical trial NCT03894748: Efficacy and Safety Study of MT10109L in the Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)
Official title: A Parallel, Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of MT10109L Versus BOTOX® in Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Glabella Line Severity
Keywords: Glabella line
Glabella lines
Botulinum Toxin
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 168
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study design is multi-center, randomized, double-blind, parallel group, active controlled, phase 3 clinical trial(Including randomized, double-blind, parallel group, active controlled, preliminary study). 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 4 weeks, 10weeks, 16weeks and efficacy and safety assessments will be conducted for total 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Main inclusion criteria

  1. Patients attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella line at maximum frown
* Other inclusion criteria

  1. Men and women aged between 20 and 65
  2. Patients who him/herself or him/her legal representatives voluntarily signed the informed consent
  3. Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

1. Patients with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis)
2. Patients who have bleeding tendency or taking anti-coagulant
3. Patients suffering from acute diseases
4. Patients who have been injected with botulinum toxin within past 3 months before the injection
5. Patients with allergy or hypersensitivity to the investigational products or their components
6. Patients who are pregnant or lactating or found pregnancy through the urine or serum test or disagreed to avoid pregnancy during 16 weeks study period

   \* All childbearing female subjects, excepting who had amenorrhea over 12 months or sterilization operation(bilateral tubal ligation, bilateral oophorrectomy or hysterectomy), shouldn't be enrolled the study until they tested negative on pregnancy test(urine or serum). The contraceptions which are medically allowable are spermicides, oral contraceptives, barrier method, intrauterine contrace, complete sexual abstinence
7. Patients who have been given any of the following drugs within previous 4 weeks at screening

   * ① Muscle relaxants: Tubocurarine Chloride, Dantrolene Sodium, baclofen etc.
   * ② Spectinomycin HCl
   * ③ Aminoglycoside antibiotics: gentamicin sulfate, neomycin sulfate etc.
   * ④ Polypeptide antibiotics: Polymyxin B Sulfate etc.
   * ⑤ Tetracycline antibiotics
   * ⑥ Lincomycin (lincosamides)
   * ⑦ Anticholinergic drugs: butylbromide bromide, Trihexyphenidyl HCl etc.
   * ⑧ Benzodiazepines and similar drugs: Diazepam, Etizolam etc.
   * ⑨ Benzamide drugs: Tiapride HCl, Sulpiride etc.
8. Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
9. Patients with skin damage or infection at the injection site.
10. Patients who have received or have a plan to receive other procedures which may affect glabella and forehead lines within 6 months

    \* These treatments include soft tissue augmentation in the range of glabella (e.g. hyaluronic acid or collagen-type implants), medium depth peels, facial lifting, dermal photorejuvenation et cetera.
11. Patients whose glabella lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
12. Patients who are participating in other clinical trials or have participated in other clinical trials within 30days of the screening date.
13. Patients who are unable to communicate or follow the instructions
14. 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: 16 weeks after the injection
measure: Investigator's live assessment of glabella line improvement rate
timeFrame: 4, 16 weeks after the injection
measure: Investigator's photographic assessment of glabella line improvement rate
timeFrame: 4 weeks after the injection
measure: Investigator's photographic assessment of glabella line improvement rate
timeFrame: 4 weeks after the injection
measure: Subject's assessment of glabella line improvement rate
timeFrame: 4, 10, 16 weeks after the injection
measure: Subject's satisfaction questionnaire
timeFrame: 4, 10, 16 weeks after the injection
measure: Number of adverse events in subjects
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Paul's Hospital
state: Dongdaemun-gu
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Jung-gu
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
state: Kangdong-gu
Study officials:
affiliation: Catholic University of Korea Saint Paul's Hospital
name: Hoon Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Gwang Seong Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyung Hee University Hospital at Gangdong
name: Woo Young Sim, M.D.
role: PRINCIPAL_INVESTIGATOR
References: