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

NCT05801146 | Unknown Phase 3

• 1 other identifier: HG-102GL-PIII-01
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Responder rate of improvement in glabellar lines with Physician's rating line severity

  Baseline to week 8, 12, 16

• Responder rate of improvement in glabellar lines with investigator's photo assessment

  Baseline to week 4, 8, 12, 16

• Responder rate of improvement in glabellar lines with investigator's photo assessment

  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

• Responder rate of improvement in glabellar lines with Subject's improvement assessment

  Baseline to week 4, 8, 12, 16

Study Arms (2)

Botulinum toxin type A(HG102)

EXPERIMENTAL

Drug: Botulinum Toxin Type A Injection [HG102]

Botulinum toxin type A(Botox®)

ACTIVE COMPARATOR

Drug: Botulinum Toxin Type A Injection [Botox]

Interventions

Botulinum Toxin Type A Injection [HG102] DRUG

Single administration, Day 0, 20 units

Also known as: HG102

Botulinum toxin type A(HG102)

Botulinum Toxin Type A Injection [Botox] DRUG

Single administration, Day 0, 20 units

Also known as: Botox®

Botulinum toxin type A(Botox®)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects that fit all of the criteria below were selected for this clinical trial.
• Male and female adults from 19 to 65 years old at the time of screening
• Person with moderate or severe glabellar lines and have received Grade 2-3 according to Physician's Rating Line Severity at maximum frown
• Person who understands and can comply to the process and visiting schedule of this clinical study
• Person who gave spontaneous written consent to participate in this clinical study

You may not qualify if:

• Subjects that fit any of the criteria below were excluded from this clinical trial.
• Person with infection, skin disease, or scar on forehead
• Person with symptoms of facial palsy or blepharoptosis
• Person with allergies or hypersensitive reaction history to the ingredients in the investigational product (botulinum toxin formula, serum albumin, etc.)
• Person who were administered with similar medication within 12 weeks (botulinum toxin type A medication) or 16 weeks (botulinum toxin type B medication)
• 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
• 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
• Other person who the investigator judges as inappropriate for the clinical trial

Sponsors & Collaborators

• Hugel: lead

Study Sites (1)

Hugel

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Central Study Contacts

Cho Long Park

CONTACT

+82-2-6966-1654; clpark@hugel.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: January 4, 2024
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)