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

Last updated: January 11, 2024
Sponsor: Hugel
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Botulinum Toxin Type A Injection [Botox]

Botulinum Toxin Type A Injection [HG102]

Clinical Study ID

NCT05801146
HG-102GL-PIII-01
  • Ages 19-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 2-3according to Physician's Rating Line Severity at maximum frown
  3. Person who understands and can comply to the process and visiting schedule ofthis clinical study
  4. Person who gave spontaneous written consent to participate in this clinical study

Exclusion

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 inthe investigational product (botulinum toxin formula, serum albumin, etc.)
  4. Person who were administered with similar medication within 12 weeks (botulinumtoxin 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 areplanning to get pregnant during the clinical study period, or do not agree to thesuitable contraceptive methods
  6. Person who participated in another clinical trial, or were given medication forother 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

Study Design

Total Participants: 272
Treatment Group(s): 2
Primary Treatment: Botulinum Toxin Type A Injection [Botox]
Phase: 3
Study Start date:
January 04, 2024
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Chung-Ang University Hopspital

    Seoul, Dongjak-gu
    Korea, Republic of

    Site Not Available

  • Hugel

    Seoul,
    Korea, Republic of

    Active - Recruiting

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