MedTrace Logo

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

NCT03837561 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2020-07-29

No results posted yet for this study

Summary

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

Conditions

  • Glabellar Frown Lines

Interventions

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.

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.

Sponsors & Collaborators

  • Medy-Tox

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2019-03-12
Completion
2019-06-03

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03837561 on ClinicalTrials.gov