To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines.

Glabellar Lines Clinical Trial

Official title:

Double-blinded, Randomized, Active Control, Single Center-designed, Phase I Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "HG-102" Compared to Botox® in Subjects With Moderate to Severe Glabellar Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04944953
• Other study ID #: HG-BOT102GL-PI-01
• Status: Completed
• Phase: Phase 1
• Start date: June 11, 2021
• Est. completion date: December 16, 2021

Study information

• Verified date: May 2022
• Source: Hugel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.

Description:

Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with moderate to severe Glabellar Lines

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 16, 2021
• Est. primary completion date: September 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Men and women aged between 19 and 65 at screening visit.

• Patients who voluntarily sign the informed consent.

• Patients who can comply with the study procedures and visit schedule.

Exclusion Criteria:

• Patients with infection, skin disorders, or scars at the glabellar region.

• Patients with facial palsy or the symptoms of blepharoptosis.

• Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.

• Subjects who are not eligible for this study based on investigator's judgement.

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

Drug:
• Botulinum Toxin Type A Injection [Botox]
Single administration, Day 0, 20 units
• Botulinum toxin type A injection [HG-102]
Single administration, Day 0, 20 units

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Hugel

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event and adverse drug reaction incidence rates		Baseline to week 16
Primary	Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel		16 weeks (during the clinical trial)
Secondary	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, 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 maximum frown with investigator's photo assessment at 4, 8, 12, 16 weeks post injection	Baseline to week 4, 8, 12, 16
Secondary	Responder rate of improvement in glabellar lines with Physician's rating line severity	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	Changes in grade by physician's rating line severity for glabellar lines	Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline	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	Subject's satisfaction rate	Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection	Baseline to week 4, 8, 12, 16
Secondary	The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)	The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain))	Baseline