Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines

Study Overview
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Brief Summary
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A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.

Official Title
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A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines

Conditions
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Glabellar Lines

Intervention / Treatment
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* Drug: CKDB-501A
* Drug: Botox®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS) Exclusion Criteria: Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function History of facial nerve paralysis or ptosis Significant facial asymmetry Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Active-controlled
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKDB-501A<br> | Drug: CKDB-501A<br>* Intramuscular injection CKDB-501A<br>|
| Active Comparator: Botox®<br> | Drug: Botox®<br>* Intramuscular injection Botox®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | severity and frequency of reported adverse events | up to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit | using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe)) | Week 4, 8, 12 | 
| Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit | using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe)) | Week 4, 8, 12 | 
| Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit | using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe)) | Week 4, 8, 12 | 
| Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit | using the Subject Assessment 9-grade Scale(range from -4(very marked worsening) to +4(complete inprovement) | Week 4, 8, 12 | 
| Subject-assessed satisfaction scale at each follow-up visit | using the Subject Satisfaction 7-point Scale(range from 1(very dissatisfied) to 7 (very satisfied) | Week 4, 8, 12 |