Efficacy and Safety Study of MT10109L in the Treatment of Glabella Line(Including a Preliminary Study to Evaluate Safety of MT10109L)

NCT ID: NCT03894748

Last Updated: 2019-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2012-10-31

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.

Conditions

Glabella Line Severity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MT10109L(Botulinum toxin type A)

Group Type: EXPERIMENTAL

Botulinum Toxin Type A

Intervention Type: DRUG

20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.

BOTOX® 50U(Botulinum toxin type A)

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.

Interventions

Botulinum Toxin Type A

20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medy-Tox

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hoon Kang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Korea Saint Paul's Hospital

Gwang Seong Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Woo Young Sim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital at Gangdong

Locations

The Catholic University of Korea, St. Paul's Hospital

Seoul, Dongdaemun-gu, South Korea

Inha University Hospital

Incheon, Jung-gu, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, Kangdong-gu, South Korea

Countries

South Korea

Other Identifiers

MT_PRT_GL02

Identifier Type: -

Identifier Source: org_study_id