Essential Blepharospasm
Conditions
Brief 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
Interventions
DRUGHugeltox
1.25U\ 2.5U/site, Maximum dosage 12.5U\ 60U/person
1.25U\ 2.5U/site, Maximum dosage 12.5U\ 60U/person
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult between ages 18 and 75 years * All patients, diagnosed of essential blepharospasm, with Grade 2\ 4 of Severity of Spmasm (by Scott's Method)
Exclusion criteria
* Patients have undergone surgical surgery to treat blepharospmasm like myectomy or neurectomy * Patients with hypersensitivity history to botulinum toxin products previously * Patients with secondary blepharomspasm * Patients with hemifacialspasm * Patients with treatment following drugs ; Anticonvulsants, tranquilizers, narcotics, aminoglycoside antibiotics, muscle relaxtants like baclofen etc., blockers of parasympathetic nervous system, levodopa * Patients with previous injection of other botulinum toxin products in 3 months * Patients with any other significant neuromuscular disease like Myasthenia gravis * Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with an improvement more than one Grade of Severity of Spasm (by Scott's Method) | at 4 weeks post-injection |
Secondary
| Measure | Time frame |
|---|---|
| (1) Duration of action days | 6 months |
| (2) Grades of Severity of Spasm (by Scott's Method), Functional Visual Status | at four weeks post-injection |
| (3) Rate of patients with a Grade-0 or Grade-1 of Severity Spasm (by Scott's Method) | at four weeks post-injection |
| (4) Rate of patients with an improvement more than two Grade of Severity of Spasm (by Scott's Method) | at four weeks post-injection |
Countries
South Korea
Outcome results
None listed