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

NCT05135910 | Unknown Phase 2 FDA Drug

• 1 other identifier: HSG-201
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 4

Brief 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

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

Study Arms (1)

HSG

EXPERIMENTAL

Hallux terbinafine subungual gel

Drug: Hallux Terbinafine Subungual Gel

Interventions

Hallux Terbinafine Subungual Gel DRUG

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

Also known as: HSG

HSG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Patients with DLSO in the target toe confirmed by positive KOH and positive fungal culture for dermatophytes
• Willingness to abstain from pedicures, nail clipping, or application of nail polish or nail cosmetics to their toenails over the study period

You may not qualify if:

• History of any significant chronic fungal disease other than onychomycosis or an immunocompromised condition
• Any previous surgery to or abnormalities of the target toe that in the investigator's opinion could prevent the toenail surface area from clearing even if eradication of the DLSO infection is achieved
• Participation in another clinical study of an investigational drug or device within 3 months of screening
• No administration of oral terbinafine or another oral antifungal within 6 months of screening
• No topical antifungal used for onychomycosis or a dermatophyte infection (i.e. tinea pedis) within 3 months of screening
• No uncontrolled diabetes mellitus
• No severe psoriasis or severe atopic dermatitis

Sponsors & Collaborators

• Hallux, Inc.: lead

Study Sites (4)

OrthoArizona - East Valley Foot & Ankle Specialists

Mesa, Arizona, 85206, United States

Location

Front Range Foot and Ankle Clinic

Parker, Colorado, 80134, United States

Location

Oregon Dermatology & Research Center

Portland, Oregon, 97210, United States

Location

J&S Studies

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Onychomycosis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin 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
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)