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

• Sponsor: CKD Bio Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05292638
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.8
• Patients Per Site Per Month: 7.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Glabellar Lines	Drug: CKDB-501A; Drug: Botox®	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Active-controlledActive-controlled
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 15, 2022
• Anticipated Primary Completion Date: Jun 10, 2022
• Anticipated Study Completion Date: Jun 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CKDB-501A	Drug: CKDB-501A; Intramuscular injection CKDB-501A
Active Comparator: Botox®	Drug: Botox®; Intramuscular injection Botox®

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [up to week 12]

   severity and frequency of reported adverse events

Secondary Outcome Measures

1. Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit [Week 4, 8, 12]

   using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe))

2. Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit [Week 4, 8, 12]

   using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe))

3. Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit [Week 4, 8, 12]

   using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe))

4. Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit [Week 4, 8, 12]

   using the Subject Assessment 9-grade Scale(range from -4(very marked worsening) to +4(complete inprovement)

5. Subject-assessed satisfaction scale at each follow-up visit [Week 4, 8, 12]

   using the Subject Satisfaction 7-point Scale(range from 1(very dissatisfied) to 7 (very satisfied)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chung-Ang University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• CKD Bio Corporation

Investigators

• Principal Investigator: beomjoon Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CKD Bio Corporation
• ClinicalTrials.gov Identifier: NCT05292638
• Other Study ID Numbers: CKDB-BAGL-101
• First Posted: Mar 23, 2022
• Last Update Posted: Mar 23, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Mar 23, 2022