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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04081402
Other study ID # HU-014_P1/3_CFL
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 1, 2018
Est. completion date February 2020

Study information

Verified date September 2019
Source Huons Co., Ltd.
Contact Jungmin Yu, Researcher
Phone 070-7492-5100
Email jungmin-yu@huons.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 290
Est. completion date February 2020
Est. primary completion date November 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Biological:
HU-014
Hutox Inj(Clostridium botulinum type A)
Botox Inj
Botox Inj(Clostridium botulinum type A)

Locations

Country Name City State
Korea, Republic of Huons Seoul

Sponsors (1)

Lead Sponsor Collaborator
Huons Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4] 4 weeks
See also
  Status Clinical Trial Phase
Completed NCT02248844 - Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea
Completed NCT02195687 - BOTOX® in the Treatment of Crow's Feet Lines in China Phase 3
Completed NCT01189760 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT01189747 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines Phase 3
Completed NCT01224015 - Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines Phase 3
Completed NCT02176356 - Patient Satisfaction Study of Combined Facial Treatment With BOTOX® Cosmetic, JUVÉDERM® and LATISSE® (HARMONY Study) Phase 4
Not yet recruiting NCT06402058 - A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement N/A
Completed NCT06376838 - To Prove the Non-inferiority of DLMR01 by Evaluating the Injecting Efficacy and Safety DLMR01 and Control for Patients in Crow's Feet N/A
Not yet recruiting NCT03184363 - Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study) Phase 3
Completed NCT01797081 - BOTOX® in the Treatment of Crow's Feet Lines in Japan Phase 3
Completed NCT03408236 - Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines Phase 3
Completed NCT01797094 - BOTOX® in the Treatment of Upper Facial Lines in Japan Phase 3
Completed NCT03317574 - MEDITOXIN® in Treatment of Crow's Feet Line Phase 3