Clinical trial NCT05801146: Evaluate the Safety and Efficacy of HG102 as Compared to Botox® in Subject With Moderate to Severe Glabellar Lines
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Glabellar Lines
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2023-04-06
Enrollment: 272
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Responder rate of improvement in glabellar lines with Physician's rating line severity
timeFrame: Baseline to week 4
Secondary outcomes:
measure: Responder rate of improvement in glabellar lines with Physician's rating line severity
timeFrame: Baseline to week 8, 12, 16
measure: Responder rate of improvement in glabellar lines with investigator's photo assessment
timeFrame: Baseline to week 4, 8, 12, 16
measure: Responder rate of improvement in glabellar lines with investigator's photo assessment
timeFrame: Baseline to week 4, 8, 12, 16
measure: Independent photo evaluator-rated improvement rate of glabellar lines at rest
timeFrame: Baseline to week 4, 8, 12, 16
measure: Responder rate of improvement in glabellar lines with Subject's improvement assessment
timeFrame: Baseline to week 4, 8, 12, 16
measure: Participant-rated satisfaction after treatment
timeFrame: Baseline to week 4, 8, 12, 16
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hugel
Study officials:
References: