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Completed

NCT Number: NCT04944953

To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines.

To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.

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Key information

Conditions

Glabellar Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Konkuk University Medical Center

Seoul, Korea, 05030, South Korea

About this study

Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with moderate to severe Glabellar Lines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women aged between 19 and 65 at screening visit.
  • Patients who voluntarily sign the informed consent.
  • Patients who can comply with the study procedures and visit schedule.

Exclusion criteria

  • Patients with infection, skin disorders, or scars at the glabellar region.
  • Patients with facial palsy or the symptoms of blepharoptosis.
  • Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
  • Subjects who are not eligible for this study based on investigator's judgement.

Treatment and study plan

Botulinum Toxin Type A Injection [Botox]

Drug

Single administration, Day 0, 20 units

Other names: Botox®

Botulinum toxin type A injection [HG-102]

Drug

Single administration, Day 0, 20 units

Other names: HG-102

Primary outcomes

  1. Adverse event and adverse drug reaction incidence rates

    Time frame: Baseline to week 16

  2. Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel

    Time frame: 16 weeks (during the clinical trial)

Secondary outcomes

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

    Time frame: Baseline to week 4, 8, 12, 16

    Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4, 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 maximum frown with investigator's photo assessment at 4, 8, 12, 16 weeks post injection

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

    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

  4. 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

  5. Changes in grade by physician's rating line severity for glabellar lines

    Time frame: Baseline to week 4, 8, 12, 16

    Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline

  6. 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

  7. Subject's satisfaction rate

    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

  8. The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)

    Time frame: Baseline

    The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain))

Sponsors and collaborators

Lead sponsor

Hugel

Industry

Registry information

Official study title

Double-blinded, Randomized, Active Control, Single Center-designed, Phase I Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "HG-102" Compared to Botox® in Subjects With Moderate to Severe Glabellar Lines

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 30, 2021
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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