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

NCT ID: NCT05292638

Last Updated: 2022-11-17

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

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2022-06-10

Brief Summary

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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.

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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

Active-controlled
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

* 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.)
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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, Chung-Ang University College of Medicine

Locations

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Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CKDB-BAGL-101

Identifier Type: -

Identifier Source: org_study_id

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