Safety and Efficacy of CKDB-501A in Subjects With Moderat... | NCT05292638

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

NCT05292638

Sponsor

CKD Bio Corporation

Status

Completed

Last Update Posted

Nov 17, 2022Actual

Enrollment

30Actual

Phase

Phase 1

Conditions

Glabellar Lines

Interventions

CKDB-501A
Botox®

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 15, 2022Actual

Primary Completion Date

Jun 10, 2022Actual

Completion Date

Jun 10, 2022Actual

First Submitted Date

Feb 23, 2022

First Submission Date that Met QC Criteria

Mar 14, 2022

First Posted Date

Mar 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2022

Last Update Posted Date

Nov 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKDB-501A	Experimental		Drug: CKDB-501A
Botox®	Active Comparator		Drug: Botox®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CKDB-501A	Drug	Intramuscular injection CKDB-501A	CKDB-501A
Botox®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events	severity and frequency of reported adverse events	up to week 12

Secondary Outcomes

Measure	Description	Time Frame
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))	Week 4, 8, 12
Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
beomjoon Kim	Chung-Ang University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung-Ang University Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

Not provided

Browse Branches

Not provided