To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis
Primary Purpose
Onychomycosis of Toenail
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hallux Terbinafine Subungual Gel
Sponsored by
About this trial
This is an interventional treatment trial for Onychomycosis of Toenail focused on measuring Onychomycosis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- OrthoArizona - East Valley Foot & Ankle Specialists
- Front Range Foot and Ankle Clinic
- Oregon Dermatology & Research Center
- J&S Studies
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HSG
Arm Description
Hallux terbinafine subungual gel
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Clinical Cure in the Target Toe
100% healthy, clear nail
Mycological Cure in the Target Toe
Negative KOH, negative fungal culture
Positive Response in the Target Toe
≥ 80% decrease in disease involvement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05135910
Brief Title
To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis
Official Title
An Open Label Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Hallux Terbinafine Subungual Gel Administered to the Toenail Bed of Patients With Distal-Lateral Subungual Onychomycosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hallux, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
Primary Efficacy: To identify patients achieving Complete Cure in the target toenail at Week 52.
Secondary Efficacy: To identify patients that have achieved 1) Clinical Cure, 2) Mycological Cure, and/or 3) Positive Response in the target toenail at Week 52.
Plasma Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in a subpopulation of patients over the study period.
Nail Pharmacokinetics: To characterize concentrations of terbinafine and major metabolite in distal nail clippings in patients over the study period.
HSG Safety and Tolerability Profile: To establish from plasma pharmacokinetics, related adverse events, treatment site reactions, pain, clinically significant changes in medical condition and/or medications, and clinically significant changes in liver function, serum chemistry, urinalysis, and complete blood count over the study period.
Subungual Topical Procedure: To establish the ease and durability of once monthly and once bi-monthly HSG subungual topical treatments, the Investigator will record at selected time points 1) nail measurements indicating progressive clearing, 2) the ease and depth of each topical administration, 3) the investigational drug volume administered each treatment, and 4) patient tolerability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail
Keywords
Onychomycosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HSG
Arm Type
Experimental
Arm Description
Hallux terbinafine subungual gel
Intervention Type
Drug
Intervention Name(s)
Hallux Terbinafine Subungual Gel
Other Intervention Name(s)
HSG
Intervention Description
Hallux Terbinafine Subungual Gel (HSG) administered every 1 to 2 months over 44 weeks.
Primary Outcome Measure Information:
Title
Complete Cure at Week 52 in the Target Toe
Description
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).
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Clinical Cure in the Target Toe
Description
100% healthy, clear nail
Time Frame
Week 52
Title
Mycological Cure in the Target Toe
Description
Negative KOH, negative fungal culture
Time Frame
Week 52
Title
Positive Response in the Target Toe
Description
≥ 80% decrease in disease involvement
Time Frame
Week 52
Other Pre-specified Outcome Measures:
Title
Plasma Pharmacokinetics
Description
To characterize plasma concentrations of terbinafine and metabolite from a subset of patients over the study period
Time Frame
Week 52
Title
Nail Pharmacokinetics
Description
To characterize nail concentrations of terbinafine and metabolite from patients over the study period
Time Frame
Week 52
Title
Subungual Topical Procedure
Description
To evaluate the ease and durability of once monthly and once bi-monthly HSG subungual topical treatments to the target toe over 44 weeks. Nail measurements indicating progressive clearing are recorded from an Investigator Global Assessment scale referencing % disease involvement corroborated by nail image analysis. The ease and durability of subungual topical treatment is established using a 5-point Likert Scale. Patient local tolerability is established using a Treatment Site Assessment Scale and Pain Intensity Scale.
Time Frame
Week 44
Title
Patient Global Assessment
Description
To establish each patient's impression of DLSO improvement in their target toe over the study period, patients will reference the following scale (0 = clear of DLSO, 1 = marked improvement of DLSO, 2 = moderately improved DLSO, 3 = slightly improved DLSO, 4 = unchanged, 5 = worse)
Time Frame
Week 52
Title
Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events
Description
Indicated by the number of patients with treatment-related adverse events assessed by Common Terminology Criteria for Adverse Events (CTCAE)
Time Frame
Monitored from screening visit to end of study visit (Week 52)
Title
Safety and Tolerability: Established from clinical laboratory results
Description
Indicated by clinically significant changes in patient liver function, serum chemistry, urinalysis, and complete blood count over the study period
Time Frame
Monitored at selected time points from screening visit to end of study visit (Week 52)
Title
Safety and Tolerability: Established from patient reported medical condition and use of medications
Description
Monitored by assessing clinically significant changes in patient medical condition and/or use of medications over the study period
Time Frame
Monitored from screening visit to end of study visit (Week 52)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lewis H. Freed, DPM
Organizational Affiliation
OrthoArizona, East Valley Foot & Ankle Specialists
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Terry M. Jones, MD
Organizational Affiliation
J&S Studies
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel P. Mallett, DPM
Organizational Affiliation
Front Range Foot and Ankle Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phoebe Rich, MD
Organizational Affiliation
Oregon Dermatology and Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoArizona - East Valley Foot & Ankle Specialists
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Front Range Foot and Ankle Clinic
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
J&S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This is a phase II study. Individual participant data (IPD) of this study will not be shared.
Learn more about this trial
To Evaluate Hallux Terbinafine Subungual Gel (HSG) in the Treatment of Onychomycosis
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