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
1 other identifier
interventional
38
1 country
1
Brief Summary
To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2021
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2021
CompletedStudy Start
First participant enrolled
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2021
CompletedMay 24, 2022
May 1, 2022
3 months
June 11, 2021
May 23, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
Responder rate of improvement in glabellar lines with Physician's rating line severity
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
Responder rate of improvement in glabellar lines with Physician's rating line severity
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
Changes in grade by physician's rating line severity for glabellar lines
Baseline to week 4, 8, 12, 16
- +3 more secondary outcomes
Study Arms (2)
Botulinum toxin type A(Botox®)
ACTIVE COMPARATORBotulinum toxin type A(Botox®) 100 Unit
Botulinum toxin type A(HG-102)
EXPERIMENTALBotulinum toxin type A(HG-102) 100 Unit
Interventions
Single administration, Day 0, 20 units
Single administration, Day 0, 20 units
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hugellead
Study Sites (1)
Konkuk University Medical Center
Seoul, Korea, 05030, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2021
First Posted
June 30, 2021
Study Start
June 11, 2021
Primary Completion
September 2, 2021
Study Completion
December 16, 2021
Last Updated
May 24, 2022
Record last verified: 2022-05