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

NCT ID: NCT04944953

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-11

Study Completion Date

2021-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glabellar Lines

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Botulinum toxin type A(Botox®)

Botulinum toxin type A(Botox®) 100 Unit

Group Type ACTIVE_COMPARATOR

Botulinum Toxin Type A Injection [Botox]

Intervention Type DRUG

Single administration, Day 0, 20 units

Botulinum toxin type A(HG-102)

Botulinum toxin type A(HG-102) 100 Unit

Group Type EXPERIMENTAL

Botulinum toxin type A injection [HG-102]

Intervention Type DRUG

Single administration, Day 0, 20 units

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Botulinum Toxin Type A Injection [Botox]

Single administration, Day 0, 20 units

Intervention Type DRUG

Botulinum toxin type A injection [HG-102]

Single administration, Day 0, 20 units

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Botox® HG-102

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hugel

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Konkuk University Medical Center

Seoul, Korea, South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HG-BOT102GL-PI-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.