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

NCT03894748 | Completed Phase 2

• 1 other identifier: MT_PRT_GL02
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

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

Keywords

Glabella line; Glabella lines; Botulinum Toxin

Outcome Measures

Primary Outcomes (1)

• Investigator's live assessment of glabella line improvement rate

  Glabella line improvement rate determined by investigator's live assessment of glabella line severity at maximum frown

  4 weeks after the injection

Secondary Outcomes (7)

• Investigator's live assessment of glabella line improvement rate

  16 weeks after the injection

• Investigator's live assessment of glabella line improvement rate

  4, 16 weeks after the injection

• Investigator's photographic assessment of glabella line improvement rate

  4 weeks after the injection

• Investigator's photographic assessment of glabella line improvement rate

  4 weeks after the injection

• Subject's assessment of glabella line improvement rate

  4, 10, 16 weeks after the injection

Study Arms (2)

MT10109L(Botulinum toxin type A)

EXPERIMENTAL

Drug: Botulinum Toxin Type A

BOTOX® 50U(Botulinum toxin type A)

ACTIVE COMPARATOR

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A 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); MT10109L(Botulinum toxin type A)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• 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 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
• 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.

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (3)

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

Seoul, Dongdaemun-gu, South Korea

Location

Inha University Hospital

Incheon, Jung-gu, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, Kangdong-gu, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Hoon Kang, M.D.

  Catholic University of Korea Saint Paul's Hospital

  PRINCIPAL INVESTIGATOR

• Gwang Seong Choi, M.D., Ph.D.

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Woo Young Sim, M.D.

  Kyung Hee University Hospital at Gangdong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: March 28, 2019
• Study Start: December 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

KR (3)