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A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01891305
Recruitment Status : Completed
First Posted : July 3, 2013
Results First Posted : July 6, 2018
Last Update Posted : August 1, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: VT-1161 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: VT-1161 200/50mg Drug: VT-1161
Experimental: VT-1161 600/150mg Drug: VT-1161
Experimental: VT-1161 1200/300mg Drug: VT-1161
Placebo Comparator: Matching placebo Drug: placebo

Primary Outcome Measures :
  1. Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population [ Time Frame: 6 weeks ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01891305

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United States, Alabama
Univ Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, Florida
Florida Academic Dermatology Center
Miami, Florida, United States, 33136
FXM Research
Miramar, Florida, United States, 33027
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Oregon
Oregon Dermatology & Research Center
Portland, Oregon, United States, 97210
United States, Texas
J&S Studies, Inc.
College Station, Texas, United States, 77845
United States, Virginia
Pariser Dermatology Specialists
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators

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Responsible Party: Viamet Identifier: NCT01891305    
Other Study ID Numbers: VMT-VT-1161-CL-003
First Posted: July 3, 2013    Key Record Dates
Results First Posted: July 6, 2018
Last Update Posted: August 1, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Tinea Pedis
Skin Diseases, Infectious
Skin Diseases
Foot Dermatoses
Foot Diseases
Skin Manifestations
Signs and Symptoms