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OpenTrials
Completed

NCT Number: NCT03837561

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.

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical Center Capital-Health

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cunox

Drug

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.

Botox

Drug

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.

Primary outcomes

  1. Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity

    Time frame: at 4 weeks after the injection.

    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.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2019
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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