The Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

Medytox

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Drug: Cunox; Drug: Botox

Study type: Interventional

Funder types: Industry

Identifiers

NCT03837561

MT01-RU18GBL301

Details and patient eligibility

About

To Confirm the non-inferiority of CUNOX® to BOTOX® in the glabellar line improvement of moderate to severe glabellar lines.

Enrollment: 136 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged between 18 and 65
• Subjects attaining ≥ grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum forced frown
• Subjects who voluntarily sign the informed consent

Exclusion criteria

• Subjects with allergy or hypersensitivity to the investigational drugs or their components
• Subjects who are participating in other clinical trials or have participated in clinical trials 30 days before screening
• Subjects who are not eligible for this study at the discretion of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups

Cunox

Experimental group

Description:

Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.

Treatment:

Drug: Cunox

Botox

Active Comparator group

Description:

Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.

Treatment:

Drug: Botox