Clinical trial NCT01891305: A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
Official title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Moderate to Severe Interdigital Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Lead sponsor: Viamet
Sponsor class: INDUSTRY
First posted: 2013-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the novel oral agent VT-1161 is safe and effective in treating patients with moderate - severe tinea pedis (also referred to as athletes foot). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this results in many of the side effects associated with the azole antifungals. The safety profile of the class similarly limits use in chronic treatment of non-life-threatening fungal infections. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.


Eligibility criteria: Key Inclusion Criteria:

* Healthy male and non-pregnant female patients ≥18 years and \<65 years
* Clinical diagnosis of tinea pedis
* Positive baseline KOH
* Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)
* Patients must be able to swallow capsules intact
* Use acceptable birth control methods

Key Exclusion Criteria:

* Major organ system disease or clinical infection
* Poorly controlled diabetes mellitus
* Pregnant or lactating
* Confluent, diffuse moccasin-type tinea pedis
* Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail
* Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot
* Recent use of systemic corticosteroids or antifungal therapy
* Known(HIV)infection
* Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.

Primary outcomes:
measure: Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ Alabama at Birmingham
state: Alabama
city: Miami
country: United States
facility: Florida Academic Dermatology Center
state: Florida
city: Miramar
country: United States
facility: FXM Research
state: Florida
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology & Research Center
state: Oregon
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Norfolk
country: United States
facility: Pariser Dermatology Specialists
state: Virginia
Study officials:
References: