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
Overview
- Phase
- Phase 1
- Intervention
- Botulinum Toxin Type A Injection [Botox]
- Conditions
- Glabellar Lines
- Sponsor
- Hugel
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Adverse event and adverse drug reaction incidence rates
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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
Investigators
Eligibility Criteria
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.
Arms & Interventions
Botulinum toxin type A(Botox®)
Botulinum toxin type A(Botox®) 100 Unit
Intervention: Botulinum Toxin Type A Injection [Botox]
Botulinum toxin type A(HG-102)
Botulinum toxin type A(HG-102) 100 Unit
Intervention: Botulinum toxin type A injection [HG-102]
Outcomes
Primary Outcomes
Adverse event and adverse drug reaction incidence rates
Time Frame: Baseline to week 16
Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel
Time Frame: 16 weeks (during the clinical trial)
Secondary Outcomes
- Responder rate of improvement in glabellar lines with Physician's rating line severity(Baseline to week 4, 8, 12, 16)
- Responder rate of improvement in glabellar lines with investigator's photo assessment(Baseline to week 4, 8, 12, 16)
- Responder rate of improvement in glabellar lines with Subject's improvement assessment(Baseline to week 4, 8, 12, 16)
- Changes in grade by physician's rating line severity for glabellar lines(Baseline to week 4, 8, 12, 16)
- Subject's satisfaction rate(Baseline to week 4, 8, 12, 16)
- The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)(Baseline)