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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: Botulinum Toxin Type A Injection [Botox]; Drug: Botulinum Toxin Type A Injection [HG102]

• Study Type: Interventional
• Enrollment (Estimated): 272
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Cho Long Park; Phone Number: +82-2-6966-1654; Email: clpark@hugel.co.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Hugel
    • Contact: ChoLong Park

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum toxin type A(Botox®)	Drug: Botulinum Toxin Type A Injection [Botox]; Single administration, Day 0, 20 units; Other Names: Botox®
Experimental: Botulinum toxin type A(HG102)	Drug: Botulinum Toxin Type A Injection [HG102]; Single administration, Day 0, 20 units; Other Names: HG102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate of improvement in glabellar lines with Physician's rating line severity	Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4 weeks post injection	Baseline to week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder rate of improvement in glabellar lines with investigator's photo assessment	Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection	Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Subject's improvement assessment	Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection	Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Physician's rating line severity	Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection	Baseline to week 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment	Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection	Baseline to week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest		Baseline to week 4, 8, 12, 16
Participant-rated satisfaction after treatment	Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection	Baseline to week 4, 8, 12, 16

Collaborators and Investigators

• Sponsor: Hugel
• Investigators: Principal Investigator: Ju Hee Lee, MD, PhD, Severance Hospital; Principal Investigator: Si Hyung Lee, MD, PhD, Seoul National University Hospital; Principal Investigator: Ik Joon Moon, MD, PhD, Asan Medical Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: HG-102GL-PIII-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No