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

Glabellar Lines Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801146
• Other study ID #: HG-102GL-PIII-01
• Status: Recruiting
• Phase: Phase 3
• Start date: January 4, 2024
• Est. completion date: October 2025

Study information

• Verified date: January 2024
• Source: Hugel
• Contact: Cho Long Park
• Phone: +82-2-6966-1654
• Email: clpark[@]hugel.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 272
• Est. completion date: October 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

Drug:
• Botulinum Toxin Type A Injection [HG102]
Single administration, Day 0, 20 units
• Botulinum Toxin Type A Injection [Botox]
Single administration, Day 0, 20 units

Locations

Country	Name	City	State
Korea, Republic of	Hugel	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Independent photo evaluator-rated improvement rate of glabellar lines at rest		Baseline to week 4, 8, 12, 16
Secondary	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
Secondary	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