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

A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A 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-501A in Glabellar lines.

Study Overview

• Status: Completed
• Conditions: Glabellar Lines
• Intervention / Treatment: Drug: CKDB-501A; Drug: Botox®

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CKDB-501A	Drug: CKDB-501A; Intramuscular injection CKDB-501A
ACTIVE_COMPARATOR: Botox®	Drug: Botox®; Intramuscular injection Botox®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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	using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe))	Week 4, 8, 12
Changes in the investigator-assessed glabellar line severity score from baseline 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 subject's assessment of glabellar line severity at each follow-up visit	using the Subject Assessment 9-grade Scale(range from -4(very marked worsening) to +4(complete inprovement)	Week 4, 8, 12
Subject-assessed satisfaction scale at each follow-up visit	using the Subject Satisfaction 7-point Scale(range from 1(very dissatisfied) to 7 (very satisfied)	Week 4, 8, 12

Collaborators and Investigators

• Sponsor: CKD Bio Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2022
• Primary Completion (ACTUAL): June 10, 2022
• Study Completion (ACTUAL): June 10, 2022

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (ACTUAL): March 23, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CKDB-BAGL-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No