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

Launched by HUGEL · Mar 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HG102 to see how safe and effective it is for reducing moderate to severe glabellar lines, which are the wrinkles that form between your eyebrows when you frown. The trial compares HG102 to Botox®, a well-known treatment for these lines, to determine if HG102 works just as well. The study is currently looking for participants who are adults between the ages of 19 and 65, have noticeable glabellar lines, and are willing to follow the study’s guidelines and schedule.

If you decide to participate, you will receive either HG102 or Botox® and will be monitored for safety and effectiveness throughout the trial. However, certain individuals cannot join, such as those with skin infections or certain allergies, and those who have recently used similar treatments. It's important to know that this trial aims to provide more options for people seeking to reduce their facial lines, potentially benefiting many in the future.

Gender

ALL

Eligibility 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