Efficacy and Safety Assessment of Botulax® and BOTOX® for Improvement of Glabellar Lines.

NCT05380154 | Completed Phase 3

• 1 other identifier: Botulax-3001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 3 clinical trial of multi-center, random, blinded\*, parallel control, and positive control to evaluate the efficacy and safety of Botulax® Injection compared to BOTOX® for improving moderate to severe glabellar wrinkles.

Conditions

Glabellar Lines

Keywords

botulinum toxin type A; Glabellar lines; wrinkles

Outcome Measures

Primary Outcomes (1)

• Responder rate of improvement in glabellar lines with Physician's rating of line severity

  The rate of test subjects receiving 0 or 1 point by the institution evaluator who assesses the glabellar wrinkles (at maximum frown) at the site in week 4.

  Week 4

Secondary Outcomes (6)

• Responder rate of improvement in glabellar lines with Physician's rating of line severity

  weeks 1, 8, 12, and 16 after the treatment

• Responder rate of improvement in glabellar lines at rest with Physician's assessment of severity

  weeks 1, 4, 8, 12, and 16 after the treatment

• Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment

  weeks 1, 4, 8, 12, and 16 after the treatment

• Responder rate of improvement in glabellar lines at rest with investigator's photo assessment

  weeks 1, 4, 8, 12, and 16 after the treatment

• Responder rate of improvement in glabellar lines with Subject's improvement assessment

  weeks 1, 4, 8, 12, and 16 after the treatment

Study Arms (2)

Test group

EXPERIMENTAL

Botulinum Toxin A type for injection (Botulax®)

Drug: Botulinum Toxin A type for injection (Botulax®)

control group

ACTIVE COMPARATOR

Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)

Drug: Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®)

Interventions

Botulinum Toxin A type for injection (Botulax®) DRUG

Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects

Test group

Botulinum Toxin A type for injection (BOTOX®, Bao Tuo Shi®) DRUG

Person in charge of dilution uses 0.9% sodium chloride injection solution to formulate the drug substance into 4U/0.1mL composite solution, and the investigator injects it into the test subjects.

control group

Eligibility Criteria

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

You may qualify if:

• Aged 18 - 65 years (inclusive), no gender preference
• The evaluator at each institution assesses the severity level of glabellar wrinkles at the site in the field when the test subject frowns as much as possible according to the 4-point photographic evaluation table and classifies the subjects with a rating of ≥ 2 (medium or severe).
• Persons who can follow the test well, fully understand the clinical trial, rationally foresee the cost-effectiveness of injection, and adhere to the study procedure until the end of the clinical trial are selected.
• The test subjects fully understand the test requirements and voluntarily sign the consent form.

You may not qualify if:

• Subjects who have a history of oversensitivity to the Botulinum Toxin A type, Botulinum Toxin B type, or other control groups of the tested drug substance.
• Subjects with clear scars, infections, a carcinogenic or cancerous metastatic lesion on the upper part of the face and/or unrecovered wounds on the face.
• Subjects with skin disease, such as dermatitis and acne, or scar on the face, which the investigator judges can affect the evaluation of treatment effectiveness or safety of the test subject.
• Subjects who took anticoagulant drugs (e.g., aspirin, nonsteroidal anti-inflammatory drugs, clopidogrel, warfarin, etc.) within two weeks prior to selection; the test subjects who are menstruating can avoid it by delaying the injection of studied products as needed.
• Subjects who took drugs with muscle relaxation effects (e.g., muscle relaxants, Curare-like substances, anticholinergic drugs, spectinomycin hydrochloride, aminoglycoside-based drugs, polypeptide antibiotics, tetracycline, lincomycin-based drugs, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) within 4 weeks prior to selection, anticholinergics, benzodiazepines and similar drugs, or benzamide drugs) or are foreseen to use the above drugs during the study period (for 16 weeks after the injection treatment).
• Subjects who have used external medications (e.g., glucocorticoids or tretinoin ointment) on the upper part of the face within 4 weeks prior to the selection or are foreseen to use the drug on the upper part of the face during the study period (for 16 weeks after the injection treatment).
• Subjects who have a history of injecting drugs similar to the study drug within 6 months prior to selection or are foreseen to use during the study period (Botulinum Toxin A type or Botulinum Toxin B type).
• Subjects who have undergone eye shape correction, laser skin transplantation, skin surgery, IPL, frequency surgery, dermabrasion, chemical dermabrasion, or other laser resolution and nonresolution surgery within 6 months prior to selection or are foreseen to do so during the study period.
• Subjects who have had injected hyaluronic acid in the upper part of their face within 12 months prior to selection or plan to do it.
• Subjects who have a history of surgery to remove wrinkles on the face above the eyes or a permanent filling injection.
• Subjects who plan to undergo a wrinkle removal surgery on their face during the study period, an injection filling of soft tissue for wrinkle removal, or other facial plastic surgeries.
• Subjects whom the investigator judges to be unsuitable to participate in this study

Sponsors & Collaborators

• Hugel: lead
• Sihuan Pharmaceutical Limited: collaborator

Study Sites (1)

Hugel Inc.

Seoul, South Korea

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Injections

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; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators (investigator, evaluator at each institution, photographer, Independent Evaluation Committee, etc.), except for the injection mixing officer, employees of the sponsor, and test subjects are blinded during the test. Each institution appoints an independent injection formulation officer and prohibits interchange with the drug substance test group to make sure that the blinded method of the test is performed accurately
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 18, 2022
• Study Start: May 9, 2017
• Primary Completion: January 22, 2018
• Study Completion: July 6, 2018
• Last Updated: May 24, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)