Trials Sponsors Conditions Drugs Pricing

Conditions

Onychomycosis of Toenail

Keywords

Onychomycosis

Outcome Measures

Primary Outcomes (1)

Complete Cure at Week 52 in the Target Toe
Complete Cure is defined as 1) 100% healthy, clear nail, and 2) negative mycology. Healthy, clear nail is absent any disease involvement attributable to DLSO and is determined by Investigator Global Assessment (IGA). Negative mycology is defined as zero visualization of septate hyphae by KOH microscopy (negative KOH) combined with a fungal culture negative for causal dermatophytes (negative fungal culture).
Week 52

Secondary Outcomes (3)

Clinical Cure in the Target Toe
Week 52
Mycological Cure in the Target Toe
Week 52
Positive Response in the Target Toe
Week 52

Other Outcomes (7)

Plasma Pharmacokinetics
Week 52
Nail Pharmacokinetics
Week 52
Subungual Topical Procedure
Week 44
+4 more other outcomes

Study Arms (1)

HSG

EXPERIMENTAL

Hallux terbinafine subungual gel

Drug: Hallux Terbinafine Subungual Gel

Interventions

Hallux Terbinafine Subungual GelDrug

Hallux Terbinafine Subungual Gel (HSG) administered every 1 to 2 months over 44 weeks.

Also known as: HSG

HSG

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and females 18 - 75 years of age inclusive
Patients with DLSO of at least one great toe

Sponsors & Collaborators

Hallux, Inc.
Industrylead

Study Sites (4)

OrthoArizona - East Valley Foot & Ankle Specialists

Mesa, Arizona, 85206, United States

Front Range Foot and Ankle Clinic

Parker, Colorado, 80134, United States

Oregon Dermatology & Research Center

Portland, Oregon, 97210, United States

J&S Studies

College Station, Texas, 77845, United States

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Lewis H. Freed, DPM
OrthoArizona, East Valley Foot & Ankle Specialists
PRINCIPAL INVESTIGATOR
Terry M. Jones, MD
J&S Studies
PRINCIPAL INVESTIGATOR
Daniel P. Mallett, DPM
Front Range Foot and Ankle Clinic
PRINCIPAL INVESTIGATOR
Phoebe Rich, MD
Oregon Dermatology and Research Center
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 26, 2021

Study Start

January 13, 2022

Actual (reported)

Primary Completion

September 30, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (7)

Study Arms (1)

HSG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (7)

Study Arms (1)

HSG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations