A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
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
1 other identifier
interventional
50
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2013
Shorter than P25 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 3, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
July 6, 2018
CompletedAugust 1, 2018
July 1, 2018
1.3 years
June 17, 2013
June 6, 2018
July 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Study Arms (4)
VT-1161 200/50mg
EXPERIMENTALVT-1161 600/150mg
EXPERIMENTALVT-1161 1200/300mg
EXPERIMENTALMatching placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viametlead
Study Sites (7)
Univ Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Florida Academic Dermatology Center
Miami, Florida, 33136, United States
FXM Research
Miramar, Florida, 33027, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Oregon Dermatology & Research Center
Portland, Oregon, 97210, United States
J&S Studies, Inc.
College Station, Texas, 77845, United States
Pariser Dermatology Specialists
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neil Moore
- Organization
- Viamet Pharmaceuticals Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2013
First Posted
July 3, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 1, 2018
Results First Posted
July 6, 2018
Record last verified: 2018-07