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

Hugel

Status and phase: Completed; Phase 1

Conditions: Glabellar Lines

Treatments: Drug: Botulinum Toxin Type A Injection [Botox]; Drug: Botulinum toxin type A injection [HG-102]

Study type: Interventional

Funder types: Industry

Identifiers

NCT04944953

HG-BOT102GL-PI-01

Details and patient eligibility

About

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

Full 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

Enrollment: 38 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Botulinum toxin type A(Botox®)

Active Comparator group

Description:

Botulinum toxin type A(Botox®) 100 Unit

Treatment:

Drug: Botulinum Toxin Type A Injection [Botox]

Botulinum toxin type A(HG-102)

Experimental group

Description:

Botulinum toxin type A(HG-102) 100 Unit

Treatment:

Drug: Botulinum toxin type A injection [HG-102]