Back to resultsA Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
Primary Purpose
Tinea Pedis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VT-1161
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Pedis
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.
Sites / Locations
- Univ Alabama at Birmingham
- Florida Academic Dermatology Center
- FXM Research
- Wake Research Associates
- Oregon Dermatology & Research Center
- J&S Studies, Inc.
- Pariser Dermatology Specialists
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
VT-1161 200/50mg
VT-1161 600/150mg
VT-1161 1200/300mg
Matching placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01891305
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Viamet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VT-1161 200/50mg
Arm Type
Experimental
Arm Title
VT-1161 600/150mg
Arm Type
Experimental
Arm Title
VT-1161 1200/300mg
Arm Type
Experimental
Arm Title
Matching placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
VT-1161
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
Description
For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Univ Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Florida Academic Dermatology Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
FXM Research
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Pariser Dermatology Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
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