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

Glabellar Frown Lines Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03837561
• Other study ID #: MT01-RU18GBL301
• Status: Completed
• Phase: Phase 3
• Start date: December 13, 2018
• Est. completion date: June 3, 2019

Study information

• Verified date: July 2020
• Source: Medy-Tox
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 3, 2019
• Est. primary completion date: March 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Medical Center Capital-Health	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Medy-Tox

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.