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

CKD Bio

Status and phase: Completed; Phase 1

Conditions: Glabellar Lines

Treatments: Drug: CKDB-501B; Drug: Botox®50U

Study type: Interventional

Funder types: Industry

Identifiers

NCT05428930

CKDB-BAGL-102

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

CKDB-501B

Experimental group

Treatment:

Drug: CKDB-501B

Botox® 50U

Active Comparator group

Treatment:

Drug: Botox®50U