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

Phase Ⅲ, Randomized, Double-Blind, Active Controlled, Multi-Center, Clinical Trial to Evaluate the Efficacy and Safety of CUNOX® in Patients With Moderate to Severe Glabellar Lines

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

Study Overview

• Status: Completed
• Conditions: Glabellar Frown Lines
• Intervention / Treatment: Drug: Cunox; Drug: Botox

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Medical Center CAPITAL-HEALTH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cunox; Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.	Drug: Cunox; Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
Active Comparator: Botox; Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.	Drug: Botox; Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity	An investigator makes a live assessment of subject's glabellar lines at maximum frown on a 4-grade scale (0 (none), 1 (mild), 2 (moderate) and 3 (severe)) 4 weeks after the administration of the investigational drug or the comparator. 0 or 1 point is considered as "improved" and glabellar line improvement rate is calculated.	at 4 weeks after the injection.

Collaborators and Investigators

• Sponsor: Medy-Tox

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2018
• Primary Completion (Actual): March 12, 2019
• Study Completion (Actual): June 3, 2019

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MT01-RU18GBL301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No