Skin Aging
Conditions
Brief summary
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
Interventions
Single administration, Day 0, 20 units
Single administration, Day 0, 20units
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged between 18 and 65 * Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown * Patients who voluntarily sign the informed consent * Patients who can comply with the study procedures and visit schedule
Exclusion criteria
* Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy * Subjects with skin disorders, scar or infection around glabellar region * Subjects who are taking Aspirin, NSAIDS or anti-coagulant * Subjects with facial palsy or eyelid ptosis * Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome) * Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder * Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder) * Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months) * Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants * Subjects who have possibility to take the drugs listed above * Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period * Subjects who have glabellar lines that are unable to be improved with any physical method * Subjects who have history of hypersensitivity to Botulinum toxin and other agents * Subjects who are pregnant or breast-feeding * Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive * Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product * Subjects who are having trouble with acute disease * Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months * Subjects who are unable to communicate or follow the instructions * Subjects who are not eligible for this study based on investigator's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate of improvement in glabellar lines with Physician's rating of line severity | at 4 weeks post-injection | Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder rate of improvement in glabellar lines with Physician's rating of line severity | 8, 12, 16 weeks post-injection | Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection. |
| Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity | 4, 8, 12, 16 weeks post-injection | Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection |
| Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment | 4, 8, 12, 16 weeks post-injection | Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection |
| Safety evaluation in experimental drug treatment group | 4, 8, 12, 16 weeks post-injection | — |
| Responder rate of improvement in glabellar lines with Subject's improvement assessment | 4, 8, 12, 16 weeks post-injections | Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16weeks post injection |
| Subject's satisfaction rate | 4, 8, 12, 16 weeks post-injection | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection |
| Responder rate of improvement in glabellar lines at rest with investigator's photo assessment | 4, 8, 12, 16 weeks post inejection | Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection |
Countries
South Korea
Outcome results
None listed