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NCT05428930 Clinical Trial

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

Glabellar Lines Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05428930
Other study ID # CKDB-BAGL-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 22, 2022
Est. completion date October 25, 2022

Study information
Verified date November 2022
Source CKD Bio Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 25, 2022
Est. primary completion date October 25, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• CKDB-501B
Intramuscular injection CKDB-501B
• Botox®50U
Intramuscular injection Botox®50U

Locations
Country Name City State
Korea, Republic of Chung-Ang University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
CKD Bio Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events Severity and frequency of reported adverse events [Time Frame: up to week 12]
See also
  Status Clinical Trial Phase
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Completed NCT05248880 - A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines Phase 3
Completed NCT03216408 - Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines Phase 3
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Completed NCT05298449 - Phase 2 of HU-045 in Glabellar Lines Phase 2
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