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Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial

NCT ID: NCT05804656

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-13

Study Completion Date

2023-11-20

Brief Summary

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A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines

Detailed Description

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Conditions

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Glabellar Lines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

Study Groups

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CKDB-501A

Group Type EXPERIMENTAL

CKDB-501A

Intervention Type DRUG

Intramuscular injection CKDB-501A

Botox®

Group Type ACTIVE_COMPARATOR

Botox®

Intervention Type DRUG

Intramuscular injection Botox®

Interventions

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CKDB-501A

Intramuscular injection CKDB-501A

Intervention Type DRUG

Botox®

Intramuscular injection Botox®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1\. Subjects with at least moderate glabellar lines at maximum frown as determined by severity score of at least 2-point (moderate) on the Facial Wrinkle Scale (4-point FWS) as assessed by investigator.

Exclusion Criteria

1. Any medical condition that can affect the neuromuscular function
2. History of facial nerve paralysis or ptosis
3. Significant facial asymmetry
4. Subjects whose glabellar lines cannot be sufficiently improved by physical method
5. Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves
6. Subjects with skin abnormalities at potential injection sites
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CKD Bio Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beomjoon Kim

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University Hosptial

Locations

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Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Choi SY, Kim BJ, Lee YW, Kim WS, Yoon YN, Kim JS. Efficacy and Safety of CKDB-501A in Treating Moderate-To-Severe Glabellar Lines: A Randomized, Double-Blind, Active-Controlled, Multi-Center Phase III Trial. J Cosmet Dermatol. 2025 Jul;24(7):e70305. doi: 10.1111/jocd.70305.

Reference Type DERIVED
PMID: 40586136 (View on PubMed)

Other Identifiers

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CKDB-BAGL-301

Identifier Type: -

Identifier Source: org_study_id