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

NCT05135910 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-08-07

No results posted yet for this study

Summary

The key objective is to establish the efficacy, safety, tolerability, and pharmacokinetics of investigational drug Hallux Terbinafine Subungual Gel (HSG) administered over 44 weeks to patients with distal-lateral subungual onychomycosis (DLSO).

Conditions

  • Onychomycosis of Toenail

Interventions

DRUG

Hallux Terbinafine Subungual Gel

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

Sponsors & Collaborators

  • Hallux, Inc.

    lead INDUSTRY

Principal Investigators

  • Lewis H. Freed, DPM · OrthoArizona, East Valley Foot & Ankle Specialists

  • Terry M. Jones, MD · J&S Studies

  • Daniel P. Mallett, DPM · Front Range Foot and Ankle Clinic

  • Phoebe Rich, MD · Oregon Dermatology and Research Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05135910 on ClinicalTrials.gov