Treatment of Moderate to Severe Glabellar Lines (BMI2006)

Phase 3

Completed

• Conditions: Glabellar Lines
• Interventions: Biological: BMI2006; Biological: BOTOX®

• Registration Number: NCT05531968
• Lead Sponsor: BMI Korea

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

Detailed Description

Purpose of clinical trial:

The purpose of this study was to evaluate the efficacy and safety of 20U dose administration of 100 units of BMI2006 in adult patients who needed moderate or severe glabellar lines.

primary purpose Comparing the effectiveness after administration of each 20U dose of 'BMI2006 100 Units' or 'Botox® Week' for adult patients in need of moderate or severe glabellar lines, it was found that the BMI2006 injection group was non-inferior to the Botox® injection group. wanted to confirm.

secondary purpose The purpose of this study was to evaluate the safety and effectiveness of 'BMI2006 100 Units' 20U compared to 'Botox® Injection' 20U for adult patients who need moderate or severe glabellar wrinkles.

This clinical trial was designed as a multicenter, double-blind, randomized, parallel design, active-controlled Phase 3 clinical trial, and was intended for patients with moderate or severe glabellar lines.

Only those subjects who have agreed in writing to voluntarily participate in the clinical trial and who are evaluated to meet the selection/exclusion criteria are 1:1 to the test group (BMI2006 week administration group) or control group (Botox®) in the order of participation in the clinical trial was randomly assigned.

Subjects assigned with randomization numbers were intramuscularly injected (IM) with a total of 20U of clinical trial drugs in 5 places of 0.1 mL (4 U/0.1 mL) each on the glabellar line. Thereafter, at 4, 8, 12, and 16 weeks at intervals of 4 weeks, the institution was visited to evaluate the efficacy and safety for a total of 16 weeks.

Study Timeline

• Study Start: 2021-02-09
• Primary Completion: 2021-08-10
• Study Completion: 2021-09-17
• Study First Submitted: 2022-08-31
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-04
• Last Update Submitted: 2022-09-04
• Study First Posted: 2022-09-08
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

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

Exclusion Criteria

1. Patients with neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis[ALS], etc.)

2. Patients with facial palsy or blepharoptosis

3. Patients who have marked facial asymmetry

4. Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands

5. 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

6. 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)

7. Patients with skin disorders, infection or scars at the injection site

8. Patients who have received other procedures which may affect glabellar and forehead lines within 12 months prior to screening

   • Permanent soft tissue augmentation (e.g., Permanent filler, etc.)
   • Face lifting (e.g., Forehead/Browlift, Thread lifting, etc.)
   • Implant and Fat grafting

9. Patients with the history of treatment of glabellar part(including forehead) which may affect the treatment results

   • Hyaluronic Acid/Collagen fillers, Dermal resurfacing, Chemical Peeling, dermabrasion and Dermal Photorejuvenation within 6 months
   • Dermer Filler and Nonpermanent soft tissue filler within 12 months

10. Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period

11. Patients who have a history of injecting drugs similar to the investigational drugs within 6 months prior to selection or are foreseen to use Botulinum Toxin A type or Botulinum Toxin B type during the study period

12. Patients who have received Retinoids (e.g., isotretinoin, alitretinoin, etc.)

    • Systemic agents: within 6 months prior to screening
    • Topical agents: within 3 months prior to screening

13. Patients with the history of alcohol or drug addiction

14. Patients who have anxiety or mental disorder (e.g., depression) which may affect patient participation or objective efficacy assessment results based on the judgment of an investigator

15. Fertile women and men who have a plan on being pregnant during the study or are not willing to use appropriate contraception

16. Pregnant or lactating women

17. Patients with allergy or hypersensitivity to the investigational drugs or their components

18. Patients who have a disorder associated with malignant tumor, immunodeficiency(weak immune system), kidney disease, liver disease lung disease or etc., which is unsuitable for participation of the study based on the judgment of an investigator

19. Patients who have participated in other clinical trials and were received or applied with other investigational products or investigational device within 30 days prior to screening

20. Patients whom the investigator judges to be unsuitable to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI2006 100Units	BMI2006	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.
Botox®	BOTOX®	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.

Primary Outcome Measures

Name	Time	Method
Change rate of glabellar line at maximum frown confirmed with investigator's on-site assessment of FWS	0 and 4 weeks after the injection	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

Secondary Outcome Measures

Name	Time	Method
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 rest confirmed with investigator's on-site assessment of Facial Wrinkle Scale at baseline, 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 maximum frown confirmed with independent evaluator's photo assessment of Facial Wrinkle Scale at baseline, 4, 8,12, 16 weeks after the injection
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 maximum frown confirmed with investigator's on-site assessment of Facial Wrinkle Scale at baseline, 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 at rest confirmed with independent evaluator's photo assessment of Facial Wrinkle Scale at baseline, 4, 8,12, 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	Change rate of glabellar line confirmed with subject's assessment of the Subject Questionnaire that underpin the nine-scale change of glabellar line at 4, 8, 12 and 16 weeks after the injection
Satisfaction level using the Subject Satisfaction Questionnaire	4, 8, 12 and 16 weeks after the injection	Satisfaction level using the Subject Satisfaction Questionnaire that underpin the seven-scale measurement of satisfaction at 4, 8, 12 and 16 weeks after the injection

Trial Locations

Locations (3)

Chung-Ang University Hospital; 🇰🇷 Seoul, Heukseok-ro, Dongjak-gu, Korea, Republic of

Konkuk University Hospital; 🇰🇷 Seoul, Neungdong-ro, Gwangjin-gu, Korea, Republic of

Seoul Asan Medical Center; 🇰🇷 Seoul, Olympic-ro 43-gil, Songpa-gu, Korea, Republic of