Glabellar Lines
Conditions
Brief summary
To compare the safety and efficacy of HG-102 with Botox® in the improvement of moderate to severe glabellar lines.
Detailed description
Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of HG-102 compared to Botox® in subjects with moderate to severe Glabellar Lines
Interventions
Single administration, Day 0, 20 units
DRUGBotulinum toxin type A injection [HG-102]
Single administration, Day 0, 20 units
Sponsors
Hugel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged between 19 and 65 at screening visit. * Patients who voluntarily sign the informed consent. * Patients who can comply with the study procedures and visit schedule.
Exclusion criteria
* Patients with infection, skin disorders, or scars at the glabellar region. * Patients with facial palsy or the symptoms of blepharoptosis. * Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception. * Subjects who are not eligible for this study based on investigator's judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event and adverse drug reaction incidence rates | Baseline to week 16 |
| Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel | 16 weeks (during the clinical trial) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in grade by physician's rating line severity for glabellar lines | Baseline to week 4, 8, 12, 16 | Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline |
| Responder rate of improvement in glabellar lines with Subject's improvement assessment | Baseline to week 4, 8, 12, 16 | Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection |
| Responder rate of improvement in glabellar lines with Physician's rating line severity | Baseline to week 4, 8, 12, 16 | Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4, 8, 12, 16 weeks post injection |
| The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) | Baseline | The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain)) |
| Subject's satisfaction rate | Baseline to week 4, 8, 12, 16 | Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection |
| Responder rate of improvement in glabellar lines with investigator's photo assessment | Baseline to week 4, 8, 12, 16 | Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16 weeks post injection |
Countries
South Korea
Outcome results
None listed