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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02961673
Other study ID # HU-014_P1/2
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 26, 2016
Last updated April 10, 2018
Start date September 2016
Est. completion date March 2017

Study information

Verified date April 2018
Source Huons Co.,Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date March 2017
Est. primary completion date February 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility Inclusion Criteria:

- Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely

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 including fascioplasty, Prosthesis implantation within 6 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 Inj
Clostridium botulinum type A
Botox Inj
Clostridium botulinum type A

Locations

Country Name City State
Korea, Republic of Huons Seongnam-si Gyeonggi-do

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 Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1) Week 4
Primary Change from Baseline of Glabellar Lines improvement rate(Frown) Week 4
Secondary Assessment of Columbia Suicide Severity Rating Scale(C-SSRS) Week 4, Week 8, Week 12
Secondary change from Baseline of Glabellar Lines improvement rate (Frown) Week 8, Week 12
Secondary change from Baseline of Glabellar Lines improvement rate (Not frown) Week4, Week 8, Week 12
Secondary Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment Week 4, Week 8, Week 12
Secondary Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product Week 4, Week 8, Week 12
See also
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