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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Viamet Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01891305
First received: June 17, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Tinea Pedis
Drug: VT-1161
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Viamet Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • To evaluate the clinical and mycological efficacy of oral VT-1161 in patients with moderate to severe interdigital tinea pedis [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]
    Clinical and mycological efficacy will be evaluated on Day 42 by recording clinical signs and symptoms of tinea pedis infection and by screening for the fungal pathogen by KOH wet mount and fungal culture


Estimated Enrollment: 48
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VT-1161 oral
VT-1161 200 mg q.d. for 4 days, then 50 mg q.d. for 10 days
Drug: VT-1161
Placebo Comparator: Placebo oral
Matched placebo units for 14 days Manufactured to mimic VT-1161
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01891305

Locations
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
Viamet Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Viamet Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01891305     History of Changes
Other Study ID Numbers: VMT-VT-1161-CL-003
Study First Received: June 17, 2013
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Foot Dermatoses
Foot Diseases
Infection
Mycoses
Pruritus
Signs and Symptoms
Skin Diseases
Skin Diseases, Infectious
Skin Manifestations

ClinicalTrials.gov processed this record on November 25, 2014