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

Medy-Tox136 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Glabellar Frown Lines

Interventions

CunoxDRUG

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.

BotoxDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Center Capital-Health

Moscow, Russia

Outcomes

Primary Outcomes

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.

Time frame: at 4 weeks after the injection.

Data from ClinicalTrials.gov

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