Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 Trial

CKD Bio

Status and phase: Completed; Phase 3

Conditions: Glabellar Lines

Treatments: Drug: CKDB-501A; Drug: Botox®

Study type: Interventional

Funder types: Industry

Identifiers

NCT05804656

CKDB-BAGL-301

Details and patient eligibility

About

A Randomized, Double-blind, Active-controlled, Multi-center Phase 3 Trial to Investigate the Efficacy and Safety of CKDB-501A in Subjects with Moderated-to-severe Glabella Lines

Enrollment: 300 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects with at least moderate glabellar lines at maximum frown as determined by severity score of at least 2-point (moderate) on the Facial Wrinkle Scale (4-point FWS) as assessed by investigator.

Exclusion criteria

1. Any medical condition that can affect the neuromuscular function
2. History of facial nerve paralysis or ptosis
3. Significant facial asymmetry
4. Subjects whose glabellar lines cannot be sufficiently improved by physical method
5. Subjects who have a previous surgical history that could result in any anatomical changes related to corrugator muscle, procerus muscle, or any relevant nerves
6. Subjects with skin abnormalities at potential injection sites

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups

CKDB-501A

Experimental group

Treatment:

Drug: CKDB-501A

Botox®

Active Comparator group

Treatment:

Drug: Botox®