Completed

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

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What is being tested

CKDB-501A

+ Botox®

Drug
Who is being recruted

From 19 to 65 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorCKD Bio Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 15, 2022

Actual date on which the first participant was enrolled.

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 TitleA 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
NCT05292638
Principal SponsorCKD Bio Corporation
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
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)
6 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Chung-Ang University Hospital

Seoul, South KoreaOpen Chung-Ang University Hospital in Google Maps
CompletedOne Study Center