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

Glabellar Lines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05292638
• Other study ID #: CKDB-BAGL-101
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2022
• Est. completion date: June 10, 2022

Study information

• Verified date: November 2022
• Source: CKD Bio Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 10, 2022
• Est. primary completion date: June 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Glabellar Lines

Intervention

Drug:
• CKDB-501A
Intramuscular injection CKDB-501A
• Botox®
Intramuscular injection Botox®

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CKD Bio Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	severity and frequency of reported adverse events	up to week 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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