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OpenTrials
Completed

NCT Number: NCT05428930

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

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.

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Key information

Conditions

Glabellar Lines

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chung-Ang University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

CKDB-501B

Drug

Intramuscular injection CKDB-501B

Botox®50U

Drug

Intramuscular injection Botox®50U

Primary outcomes

  1. Incidence of Adverse Events

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

    Severity and frequency of reported adverse events

Sponsors and collaborators

Lead sponsor

CKD Bio Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501B in Subjects With Moderate-to-severe Glabellar Lines

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 23, 2022
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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