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

CKD Bio Corporation30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glabellar Lines

Interventions

CKDB-501ADRUG

Intramuscular injection CKDB-501A

Botox®DRUG

Intramuscular injection Botox®

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.)

Locations (1)

Chung-Ang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of Adverse Events

severity and frequency of reported adverse events

Time frame: up to week 12

Secondary Outcomes

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))

Time frame: 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))

Time frame: 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))

Time frame: 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)

Time frame: 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)

Time frame: Week 4, 8, 12

Data from ClinicalTrials.gov

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