Clinical trial NCT05135910: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Onychomycosis of Toenail
Keywords: Onychomycosis
Lead sponsor: Hallux, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Complete Cure at Week 52 in the Target Toe
timeFrame: Week 52
Secondary outcomes:
measure: Clinical Cure in the Target Toe
timeFrame: Week 52
measure: Mycological Cure in the Target Toe
timeFrame: Week 52
measure: Positive Response in the Target Toe
timeFrame: Week 52
Other outcomes:
measure: Plasma Pharmacokinetics
timeFrame: Week 52
measure: Nail Pharmacokinetics
timeFrame: Week 52
measure: Subungual Topical Procedure
timeFrame: Week 44
measure: Patient Global Assessment
timeFrame: Week 52
measure: Safety and Tolerability: Established from patient incidence of Treatment-Emergent Adverse Events
timeFrame: Monitored from screening visit to end of study visit (Week 52)
measure: Safety and Tolerability: Established from clinical laboratory results
timeFrame: Monitored at selected time points from screening visit to end of study visit (Week 52)
measure: Safety and Tolerability: Established from patient reported medical condition and use of medications
timeFrame: Monitored from screening visit to end of study visit (Week 52)
Locations:
city: Mesa
country: United States
facility: OrthoArizona - East Valley Foot & Ankle Specialists
state: Arizona
city: Parker
country: United States
facility: Front Range Foot and Ankle Clinic
state: Colorado
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: College Station
country: United States
facility: J&S Studies
state: Texas
Study officials:
affiliation: OrthoArizona, East Valley Foot & Ankle Specialists
name: Lewis H. Freed, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: J&S Studies
name: Terry M. Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Front Range Foot and Ankle Clinic
name: Daniel P. Mallett, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Dermatology and Research Center
name: Phoebe Rich, MD
role: PRINCIPAL_INVESTIGATOR
References: