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

NCT03837561 | Completed Phase 3

• 1 other identifier: MT01-RU18GBL301
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Cunox

EXPERIMENTAL

Cunox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.

Drug: Cunox

Botox

ACTIVE COMPARATOR

Botox (botulinum toxin type A), 0.1 mL injected into each of 5 sites once.

Drug: Botox

Interventions

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.

Cunox

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.

Botox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medy-Tox: lead

Study Sites (1)

Medical Center Capital-Health

Moscow, Russia

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 12, 2019
• Study Start: December 13, 2018
• Primary Completion: March 12, 2019
• Study Completion: June 3, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Locations

RU (1)