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

Hugel

Status and phase: Enrolling; Phase 3

Conditions: Glabellar Lines

Treatments: Drug: Botulinum Toxin Type A Injection [Botox]; Drug: Botulinum Toxin Type A Injection [HG102]

Study type: Interventional

Funder types: Industry

Identifiers

NCT05801146

HG-102GL-PIII-01

Details and patient eligibility

About

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.

Enrollment: 272 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 2 patient groups

Botulinum toxin type A(HG102)

Experimental group

Treatment:

Drug: Botulinum Toxin Type A Injection [HG102]

Botulinum toxin type A(Botox®)

Active Comparator group

Treatment:

Drug: Botulinum Toxin Type A Injection [Botox]