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

Last updated: September 5, 2019
Sponsor: Huons Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04081402
HU-014_P1/3_CFL
  • Ages 19-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambertsyndrome, 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 lowdose aspirin (below 325 mg/day)

  • Any condition that, in the view of the investigator, would interfere with studyparticipation

Study Design

Total Participants: 290
Study Start date:
November 01, 2018
Estimated Completion Date:
February 29, 2020

Connect with a study center

  • Huons

    Seoul,
    Korea, Republic of

    Active - Recruiting

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