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

Phase 1

Completed

• Conditions: Glabellar Lines
• Interventions: Drug: Botox®; Drug: CKDB-501A

• Registration Number: NCT05292638
• Lead Sponsor: CKD Bio Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Primary Completion: 2022-06-10
• Study Completion: 2022-06-10
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botox®	Botox®	-
CKDB-501A	CKDB-501A	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	up to week 12	severity and frequency of reported adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of