Clinical trial NCT04944953: To Compare the Safety and Efficacy of "HG-102" With Botox® in the Improvement of Moderate to Severe Glabellar Lines.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glabellar Lines
Lead sponsor: Hugel
Sponsor class: INDUSTRY
First posted: 2021-06-30
Enrollment: 38
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Adverse event and adverse drug reaction incidence rates
timeFrame: Baseline to week 16
measure: Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel
timeFrame: 16 weeks (during the clinical trial)
Secondary outcomes:
measure: Responder rate of improvement in glabellar lines with Physician's rating line severity
timeFrame: Baseline to week 4, 8, 12, 16
measure: Responder rate of improvement in glabellar lines with investigator's photo assessment
timeFrame: Baseline to week 4, 8, 12, 16
measure: Responder rate of improvement in glabellar lines with Physician's rating line severity
timeFrame: Baseline to week 4, 8, 12, 16
measure: Responder rate of improvement in glabellar lines with investigator's photo assessment
timeFrame: Baseline to week 4, 8, 12, 16
measure: Changes in grade by physician's rating line severity for glabellar lines
timeFrame: Baseline to week 4, 8, 12, 16
measure: Responder rate of improvement in glabellar lines with Subject's improvement assessment
timeFrame: Baseline to week 4, 8, 12, 16
measure: Subject's satisfaction rate
timeFrame: Baseline to week 4, 8, 12, 16
measure: The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Korea
Study officials:
References: