Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis
Lead Sponsor:
Viamet
Conditions:
Tinea Pedis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01891305
Start Date
August 1 2013
End Date
December 1 2014
Last Update
August 1 2018
Active Locations (7)
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1
Univ Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Florida Academic Dermatology Center
Miami, Florida, United States, 33136
3
FXM Research
Miramar, Florida, United States, 33027
4
Wake Research Associates
Raleigh, North Carolina, United States, 27612