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Evaluate the Safety and Efficacy of HG102 as Compared to Botox® in Subject With Moderate to Severe Glabellar Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05801146
Recruitment Status : Recruiting
First Posted : April 6, 2023
Last Update Posted : January 16, 2024
Sponsor:
Information provided by (Responsible Party):
Hugel

Brief Summary:
To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.

Condition or disease Intervention/treatment Phase
Glabellar Lines Drug: Botulinum Toxin Type A Injection [HG102] Drug: Botulinum Toxin Type A Injection [Botox] Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Compare the Efficacy and Safety of HG102 Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
Actual Study Start Date : January 4, 2024
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Botulinum toxin type A(HG102) Drug: Botulinum Toxin Type A Injection [HG102]
Single administration, Day 0, 20 units
Other Name: HG102

Active Comparator: Botulinum toxin type A(Botox®) Drug: Botulinum Toxin Type A Injection [Botox]
Single administration, Day 0, 20 units
Other Name: Botox®




Primary Outcome Measures :
  1. Responder rate of improvement in glabellar lines with Physician's rating line severity [ Time Frame: Baseline to week 4 ]
    Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection


Secondary Outcome Measures :
  1. Responder rate of improvement in glabellar lines with Physician's rating line severity [ Time Frame: Baseline to week 8, 12, 16 ]
    Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection

  2. Responder rate of improvement in glabellar lines with investigator's photo assessment [ Time Frame: Baseline to week 4, 8, 12, 16 ]
    Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection

  3. Responder rate of improvement in glabellar lines with investigator's photo assessment [ Time Frame: Baseline to week 4, 8, 12, 16 ]
    Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection

  4. Independent photo evaluator-rated improvement rate of glabellar lines at rest [ Time Frame: Baseline to week 4, 8, 12, 16 ]
  5. Responder rate of improvement in glabellar lines with Subject's improvement assessment [ Time Frame: Baseline to week 4, 8, 12, 16 ]
    Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection

  6. Participant-rated satisfaction after treatment [ Time Frame: Baseline to week 4, 8, 12, 16 ]
    Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection



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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects that fit all of the criteria below were selected for this clinical trial.

    1. Male and female adults from 19 to 65 years old at the time of screening
    2. Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown
    3. Person who understands and can comply to the process and visiting schedule of this clinical study
    4. Person who gave spontaneous written consent to participate in this clinical study

Exclusion Criteria:

  • Subjects that fit any of the criteria below were excluded from this clinical trial.

    1. Person with infection, skin disease, or scar on forehead
    2. Person with symptoms of facial palsy or blepharoptosis
    3. Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.)
    4. Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication)
    5. Pregnant and breast-feeding women, men and women in the childbearing age who are planning to get pregnant during the clinical study period, or do not agree to the suitable contraceptive methods
    6. Person who participated in another clinical trial, or were given medication for other clinical trials within 4 weeks from screening of 5 times the half-life, which period may be longer
    7. Other person who the investigator judges as inappropriate for the clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05801146


Contacts
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Contact: Cho Long Park +82-2-6966-1654 clpark@hugel.co.kr

Locations
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Korea, Republic of
Hugel Recruiting
Seoul, Korea, Republic of
Contact: ChoLong Park         
Sponsors and Collaborators
Hugel
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Responsible Party: Hugel
ClinicalTrials.gov Identifier: NCT05801146    
Other Study ID Numbers: HG-102GL-PIII-01
First Posted: April 6, 2023    Key Record Dates
Last Update Posted: January 16, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents