The Efficacy and Safety of Protoxin in Subjects With Moderate to Severe Glabellar Lines

NCT06124794 | Completed Phase 3

• 1 other identifier: PT_BTA_P3_21_EXT
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial is an extended clinical trial for test subjects who participated in the phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number) and completed follow-up observation up to 16 weeks after administration of clinical trial drugs, and evaluates the effectiveness and safety of repeated administration of protoxin in those with moderate or severe brow wrinkles.

Conditions

Glabellar Frown Lines

Keywords

Glabellar Lines; Botulinum toxin; Botulinum toxin type A

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure : We will use FWS(Facial wrinkle scale)

  In the Phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number), the improvement rate of brow wrinkles at 4 weeks after the administration of protoxin week and the improvement rate at the time of raising at 4 weeks after the administration of protoxin week in this extended clinical trial are compared and evaluated.

  4 weeks post injection compared to baseline

Secondary Outcomes (6)

• Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)

  Week 8, 12, 16

• Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)

  Week 4, 8, 12, 16

• Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)

  Week 4, 8, 12, 16

• Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)

  Week 4, 8, 12, 16

• Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)

  Week 4, 8, 12, 16

Study Arms (1)

PROTOXIN 100U (Clostridium botulinum toxin type A)

EXPERIMENTAL

PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL)

Biological: PROTOXIN

Interventions

PROTOXIN BIOLOGICAL

Clostridium botulinum toxin type A

PROTOXIN 100U (Clostridium botulinum toxin type A)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PT\_BTA\_P3\_21 (clinical trial plan number) Test subjects who participated in clinical trials and completed follow-up observation up to 16 weeks after administration of clinical trial drugs
• Men and women aged between 19 to 65 years old
• Subjects attaining ≥grade 2(moderate) in the investigator's rating of the severity of glabella lines at maximum frown
• Those who understand and comply with clinical trial procedures and visit schedules
• Subjects who voluntarily decides to participate and signs the consent form after hearing the explanation of this clinical trial.

You may not qualify if:

• A person who has or is accompanied by the following diseases at the time of screening
• A person with systemic neuromuscular junction disorder that can affect neuromuscular function \[myasthenia gravis (MG), Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis (ALS), etc.\]
• A person with a history of facial paralysis or ptosis
• A person who has skin abnormalities such as infections, skin diseases, scars, etc. at the site to be administered
• A person who has wrinkles to the extent that the glabellar lines cannot be physically flattened, such as when wrinkles are not straightened by hand
• A person who is taking the following drugs
• Within 4 weeks of screening: Drugs with muscle relaxation action, such as muscle relaxants, spectinomycin hydrochloride, aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, anticholinergics, benzodiazepines and similar drugs, and benzamide drugs \[However, for muscle relaxants, benzodiazepines and similar drugs, a person who has stably maintained administration of them from within 4 weeks from the time of screening (the same drug is maintained without changing the usage and dose), and is not expected to change in ingredients, usage, and dose of them during the clinical trial period can be enrolled\]
• A person who has administered aspirin or NSAIDs within 7 days before administration of the investigational product (However, low-dose aspirin (100 mg/day or less) administered for antithrombotic purposes is permitted)
• A person who has had procedure/surgery that may affect the wrinkles around the glabellar or forehead during the following period
• Within 48 weeks of screening: Tissue augmentation
• Within 24 weeks of screening: A person who has undergone facial plastic surgery including glabellar lines such as brow lift, dermal resurfacing, or peeling, etc.
• A person with a history of surgery or treatment around the orbit (except for double eyelid surgery, epicanthal fold (Mongolian fold) correction)
• A person who is planning to undergo facial cosmetic procedures such as dermal filler, photorejuvenation, chemical peeling, and dermabrasionduring the clinical trial period
• PT\_BTA\_P3\_21 (Clinical Trial Plan Number) A person who received similar drugs for clinical trials such as botulinum toxin A and B after visiting the end of phase 3 clinical trials)
• A person who is expected to administer botulinum toxin formulations other than this investigational product during the clinical trial period

Sponsors & Collaborators

• Protox Inc.: lead

Study Sites (3)

Chung-Ang University Hospital

Seoul, Gwangjin-gu, South Korea

Location

Konkuk University Hospital

Seoul, Gwangjin-gu, South Korea

Location

Nowon Eulji Medical Center

Seoul, Nowon-gu, South Korea

Location

Study Officials

• Beomjoon Kim, PI

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

• Yangone Lee, CI

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

• Jonghoon Lee, PI

  Nown Eulji Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Multicenter, Single group, Open, Extension Study of Phase III Clinical Trial

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 9, 2023
• Study Start: December 18, 2023
• Primary Completion: February 26, 2024
• Study Completion: June 14, 2024
• Last Updated: June 21, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)