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

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

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

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: Botulinum Toxin Type A Injection [Botox]; Drug: Botulinum toxin type A injection [HG-102]

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 05030
      • Konkuk University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Botulinum toxin type A(Botox®); Botulinum toxin type A(Botox®) 100 Unit	Drug: Botulinum Toxin Type A Injection [Botox]; Single administration, Day 0, 20 units; Other Names: Botox®
EXPERIMENTAL: Botulinum toxin type A(HG-102); Botulinum toxin type A(HG-102) 100 Unit	Drug: Botulinum toxin type A injection [HG-102]; Single administration, Day 0, 20 units; Other Names: HG-102

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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, 8, 12, 16 weeks post injection	Baseline to week 4, 8, 12, 16
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hugel

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2021
• Primary Completion (ACTUAL): September 2, 2021
• Study Completion (ACTUAL): December 16, 2021

Study Registration Dates

• First Submitted: June 11, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (ACTUAL): June 30, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

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-BOT102GL-PI-01

Drug and device information, study documents

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