Treatment of Moderate to Severe Glabellar Lines (BMI2006)

NCT05531968 | Completed Phase 3 DMC

• 1 other identifier: BMI2006-SIT-02
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 3

Brief Summary

A multicenter, double-blind, randomized, parallel design, active control, phase 3 clinical trial to evaluate the efficacy and safety of 100 units of BMI 2006 and Botox® in adult patients in need of moderate or severe glabellar lines

Conditions

Glabellar Lines

Keywords

BMI2006; BMI; Botulinum toxin; Clostridium botulinum Type A; BOTOX; BoNT-A; corrugator supercilii muscle

Outcome Measures

Primary Outcomes (1)

• Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS

  Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of Facial Wrinkle Scale at baseline and 4 weeks after the injection

  0 and 4 weeks after the injection

Secondary Outcomes (6)

• Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS

  0, 8, 12 and 16 weeks after the injection

• Change rate of glabellar line at rest confirmed with investigator's on-site assessment of FWS

  0, 4, 8, 12 and 16 weeks after the injection

• Change rate of glabellar line at maximum frown confirmed with independent evaluator's photo assessment of FWS

  0, 4, 8,12 and 16 weeks after the injection

• Change rate of glabellar line at rest confirmed with independent evaluator's photo assessment of FWS

  0, 4, 8,12 and 16 weeks after the injection

• Change rate of glabellar line confirmed with subject's assessment of the Subject Questionnaire

  4, 8, 12 and 16 weeks after the injection

Study Arms (2)

BMI2006 100Units

EXPERIMENTAL

Patients were intramuscularly injected (IM) with a total of 20U of BMI2006 in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line.

Biological: BMI2006

Botox®

ACTIVE COMPARATOR

Patients were intramuscularly injected (IM) with a total of 20U of Botox® in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line.

Biological: BOTOX®

Interventions

BMI2006 BIOLOGICAL

IM

Also known as: Clostridium botulinum Type A

BMI2006 100Units

BOTOX® BIOLOGICAL

IM

Also known as: Clostridium botulinum Type A

Botox®

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women aged between 19 and 65
• Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
• Patients who fully understand the clinical trial and voluntarily sign the informed consent

You may not qualify if:

• Patients with neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis\[ALS\], etc.)
• Patients with facial palsy or blepharoptosis
• Patients who have marked facial asymmetry
• Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
• Patients who have received the medications that cause relaxation of muscles all over the body within 4 weeks prior to screening
• Muscle Relaxants (e.g., Tubocurarine chloride, Dantrolene sodium, Baclofen, etc.)
• Spectinomycin hydrochloride
• Aminoglycoside antibiotics (e.g., Gentamicin sulfate, Neomycin sulfate, etc.)
• Polypeptide antibiotics (e.g., Polymyxin B sulfate, etc.)
• Tetracycline antibiotics
• Lincosamide antibiotics
• Aanticholinergic agent (e.g., Butylscopolamine bromide, Trihexyphenidyl hydrochloride, etc.)
• Benzodiazepines (e.g., Diazepam, Etizolam, etc.)
• Other medications that cause relaxation of muscles all over the body
• Patients who have received anticoagulant, antiplatelet agent or NSAIDs within 7 days before the first dose (Allow use of low-dose Aspirin\[325 mg/day or less\] for the antithrombotic therapy)

Sponsors & Collaborators

• BMI Korea: lead

Study Sites (3)

Chung-Ang University Hospital

Seoul, Heukseok-ro, Dongjak-gu, 06973, South Korea

Location

Konkuk University Hospital

Seoul, Neungdong-ro, Gwangjin-gu, 05030, South Korea

Location

Seoul Asan Medical Center

Seoul, Olympic-ro 43-gil, Songpa-gu, 05505, 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

• Beom Joon Kim, MD, Ph.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 8, 2022
• Study Start: February 9, 2021
• Primary Completion: August 10, 2021
• Study Completion: September 17, 2021
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

KR (3)