Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study

Onychomycosis Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability Patients With Mild to Moderate Onychomycosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933879
• Other study ID #: NVXT 1404
• Status: Completed
• Phase: Phase 2
• Start date: March 21, 2016
• Est. completion date: June 21, 2018

Study information

• Verified date: December 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis

Description:

Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: June 21, 2018
• Est. primary completion date: March 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails).

Exclusion Criteria:

• Females who are pregnant, lactating or likely to become pregnant during the study.

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• NVXT topical
topical treatment
• Placebo (Vehicle) Topical
Placebo (Vehicle) Topical

Locations

Country	Name	City	State
United States	Novum Pharmaceutical Research Services (Novum)	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients in Each Treatment Group With a Complete Therapeutic Cure	Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail	Day 365
Primary	Number of Patients in Each Treatment Group With a Complete Therapeutic Cure	Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail	Day 141
Secondary	Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure	Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail	Day 365
Secondary	Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure	Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail	Day 141
Secondary	Number of Patients in Each Treatment Group With a Mycological Cure	Mycological cure is defined as a negative KOH test and a negative fungal culture.	day 365
Secondary	Number of Patients in Each Treatment Group With a Mycological Cure	Mycological cure is defined as a negative KOH test and a negative fungal culture.	Day 141
Secondary	Number of Patients in Each Treatment Group With a Complete Clinical Cure	Complete clinical cure is defined as 0% nail involvement.	day 365
Secondary	Number of Patients in Each Treatment Group With a Complete Clinical Cure	Complete clinical cure is defined as 0% nail involvement.	Day 281
Secondary	Number of Patients in Each Treatment Group With a Complete Clinical Cure	Complete clinical cure is defined as 0% nail involvement.	Day 141
Secondary	Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure	Satisfactory clinical cure is defined as <5% of the target toenail involvement.	day 365
Secondary	Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure	Satisfactory clinical cure is defined as <5% of the target toenail involvement.	Day 281
Secondary	Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure	Satisfactory clinical cure is defined as <5% of the target toenail involvement.	Day 141