To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines

April 14, 2022 updated by: Hugel

Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines

To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
262

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dongjak-gu
      • Seoul, Dongjak-gu, Korea, Republic of
        • Chung-Ang University Hopspital
    • Jongno-Gu
      • Seoul, Jongno-Gu, Korea, Republic of
        • Seoul National University Hospital
    • Jung-Gu
      • Seoul, Jung-Gu, Korea, Republic of
        • National Medical Center
    • Nowon-Gu
      • Seoul, Nowon-Gu, Korea, Republic of
        • Eulji General Hospital
    • Seocho-Gu
      • Seoul, Seocho-Gu, Korea, Republic of
        • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Seongbuk-Gu
      • Seoul, Seongbuk-Gu, Korea, Republic of
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women aged between 18 and 65
  • Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown
  • Patients who voluntarily sign the informed consent
  • Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

  • Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy
  • Subjects with skin disorders, scar or infection around glabellar region
  • Subjects who are taking Aspirin, NSAIDS or anti-coagulant
  • Subjects with facial palsy or eyelid ptosis
  • Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)
  • Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder
  • Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)
  • Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)
  • Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants
  • Subjects who have possibility to take the drugs listed above
  • Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period
  • Subjects who have glabellar lines that are unable to be improved with any physical method
  • Subjects who have history of hypersensitivity to Botulinum toxin and other agents
  • Subjects who are pregnant or breast-feeding
  • Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive
  • Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product
  • Subjects who are having trouble with acute disease
  • Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months
  • Subjects who are unable to communicate or follow the instructions
  • Subjects who are not eligible for this study based on investigator's judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Botulinum toxin type A(Botox®)
Botulinum toxin type A
Drug: Botulinum toxin type A(Botulax®)
Single administration, Day 0, 20 units
Experimental: Botulinum toxin type A (Botulax®)
Botulinum toxin type A
Drug: Botulinum toxin type A(Botox®)
Single administration, Day 0, 20units

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Time Frame: at 4 weeks post-injection
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.
at 4 weeks post-injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety evaluation in experimental drug treatment group
Time Frame: 4, 8, 12, 16 weeks post-injection
4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Time Frame: 8, 12, 16 weeks post-injection
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection.
8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity
Time Frame: 4, 8, 12, 16 weeks post-injection
Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection
4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
Time Frame: 4, 8, 12, 16 weeks post-injection
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection
4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
Time Frame: 4, 8, 12, 16 weeks post inejection
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection
4, 8, 12, 16 weeks post inejection
Responder rate of improvement in glabellar lines with Subject's improvement assessment
Time Frame: 4, 8, 12, 16 weeks post-injections
Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection
4, 8, 12, 16 weeks post-injections
Subject's satisfaction rate
Time Frame: 4, 8, 12, 16 weeks post-injection
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
4, 8, 12, 16 weeks post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hugel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HG-11-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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