A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines

Phase 3

• Conditions: Crow's Feet Lines

• Registration Number: NCT04081402
• Lead Sponsor: Huons Co., Ltd.

Brief Summary

A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-01
• Status Verified: 2019-09
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Last Update Submitted: 2019-09-05
• Study First Posted: 2019-09-09
• Last Update Posted: 2019-09-09
• Primary Completion: 2019-11
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator

Exclusion Criteria

• Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
• From screening, Subject who get a plastic Surgery within 48 Weeks
• Subject who has skin disorder including infection and scar on injection site
• Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
• Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
• Any condition that, in the view of the investigator, would interfere with study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]	4 weeks

Trial Locations

Locations (1)

Huons; 🇰🇷 Seoul, Korea, Republic of