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

Phase 1

Completed

• Conditions: Glabellar Lines
• Interventions: Drug: Botulinum Toxin Type A Injection [Botox]; Drug: Botulinum toxin type A injection [HG-102]

• Registration Number: NCT04944953
• Lead Sponsor: Hugel

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2021-06-11
• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-21
• Study First Posted: 2021-06-30
• Primary Completion: 2021-09-02
• Study Completion: 2021-12-16
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin type A(Botox®)	Botulinum Toxin Type A Injection [Botox]	Botulinum toxin type A(Botox®) 100 Unit
Botulinum toxin type A(HG-102)	Botulinum toxin type A injection [HG-102]	Botulinum toxin type A(HG-102) 100 Unit

Primary Outcome Measures

Name	Time	Method
Adverse event and adverse drug reaction incidence rates	Baseline to week 16
Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel	16 weeks (during the clinical trial)

Secondary Outcome Measures

Name	Time	Method
Responder rate of improvement in glabellar lines with Physician's rating line severity	Baseline to week 4, 8, 12, 16	Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection
Responder rate of improvement in glabellar lines with investigator's photo assessment	Baseline to week 4, 8, 12, 16	Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection
Responder rate of improvement in glabellar lines with Subject's improvement assessment	Baseline to week 4, 8, 12, 16	Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection
Changes in grade by physician's rating line severity for glabellar lines	Baseline to week 4, 8, 12, 16	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
Subject's satisfaction rate	Baseline to week 4, 8, 12, 16	Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)	Baseline	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))

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Korea, Republic of