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

NCT05428930 | Completed Phase 1

• 1 other identifier: CKDB-BAGL-102
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Severity and frequency of reported adverse events

  [Time Frame: up to week 12]

Study Arms (2)

CKDB-501B

EXPERIMENTAL

Drug: CKDB-501B

Botox® 50U

ACTIVE COMPARATOR

Drug: Botox®50U

Interventions

CKDB-501B DRUG

Intramuscular injection CKDB-501B

CKDB-501B

Botox®50U DRUG

Intramuscular injection Botox®50U

Botox® 50U

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.)

Sponsors & Collaborators

• CKD Bio Corporation: lead

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

Location

Study Officials

• beomjoon Kim

  Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Active-controlled

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 22, 2022
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)