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Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "Hugeltox Inj." in Essential Blepharospasm

NCT01791881 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2013-02-15

No results posted yet for this study

Summary

To compare the efficacy and safety of Hugel-Tox (Botulinum toxin A, Hugel, Korea) against Botox in the treatment of Essential Blepharospasm and to get a regulatory approval from KFDA

Conditions

  • Essential Blepharospasm

Interventions

DRUG

Hugeltox

1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person

DRUG

Botulinum Toxin Type A(Botox®)

1.25U\~2.5U/site, Maximum dosage 12.5U\~60U/person

Sponsors & Collaborators

  • Hugel

    lead INDUSTRY

Principal Investigators

  • Yoon-Duck Kim, M.D., Ph.D. · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-05-31
Completion
2009-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01791881 on ClinicalTrials.gov