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CompletedNCT05428930Updated Nov 17, 2022

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

A Phase 1 interventional study of CKDB-501B and Botox®50U in Glabellar Lines, sponsored by CKD Bio Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by CKD Bio Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Glabellar Lines
03

In context

Lead sponsor

CKD Bio Corporation is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    CKDB-501B

    Drug: CKDB-501B

  • Active comparator
    Botox® 50U

    Drug: Botox®50U

Interventions

  • DrugCKDB-501B

    Intramuscular injection CKDB-501B

  • DrugBotox®50U

    Intramuscular injection Botox®50U

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events

    Severity and frequency of reported adverse events

    Time frame: [Time Frame: up to week 12]

07

Study locations

1 site
  • Chung-Ang University Hospital
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05428930
Lead sponsor
CKD Bio Corporation
Responsible party
Sponsor
First posted
Jun 23, 2022
Start date
Jun 22, 2022
Primary completion
Oct 25, 2022
Completion
Oct 25, 2022
Last update
Nov 17, 2022

Study contacts

beomjoon Kim
principal investigator · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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