A Study to Evaluate TMI-358 in the Treatment of Distal Subungual Onychomycosis

January 14, 2011 updated by: Talima Therapeutics, Inc.

A Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TMI-358 in the Treatment of Distal Subungual Onychomycosis of the Toenail

The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Radiant Research, Inc.
    • California
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
    • Florida
      • Miami, Florida, United States, 33144
        • International Dermatology Research Center
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Radiant Research, Inc.
    • Oregon
      • Portland, Oregon, United States, 97223
        • Oregon Medical Research Center
    • Texas
      • College Station, Texas, United States, 77845
        • J&S Studies, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Dermatology Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, 18 to 75 years of age, inclusive
  • Diagnosed with distal subungual onychomycosis (DSO) of the toenails
  • Great toe(s) with intact skin and intact neurologic functions
  • Great toenail(s) free of nail polish

  • At least one target great toe which has:

    • 25 to 75% involvement of the area of the nail unit (including destroyed or missing parts of the nail plate)
    • at least 2 mm of uninvolved nail growth as measured from the proximal nail fold to the most proximal point to the disease process and with no lunular involvement
    • nail unit hyperkeratosis at the most distal edge which measures no greater than 3 mm
    • a positive KOH and culture

Exclusion Criteria:

  • Any significant disease of the hepatic, renal, endocrine (including diabetes mellitus), immune systems, or other health conditions which could interfere with or confound the results of study assessments
  • Pre-existing chronic foot pain, neurologic deficit or skin disease/injury in treated foot
  • In the case of female subjects, are pregnant, nursing, or planning to become pregnant within the study period
  • History of clinically significant abnormal laboratory values, including liver function test results equal to or greater than 2 x the upper limit of normal
  • Disease-like psoriatic toenails, significant toenail abnormalities/dystrophies, toenail injuries or any other condition in the toenail which could interfere with study evaluations (e.g., prevent obtaining normal appearing nail, after clearing of onychomycosis, due to chemical damage, genetic or pigmentary disorders, etc.)
  • Have white superficial onychomycosis, proximal subungual onychomycosis, yellow spikes, or dermatophytoma
  • Have paronychia
  • Have a history of chronic alcohol or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TMI-358
Active treatment
Drug: TMI-358
Micro implant monthly x 3
PLACEBO_COMPARATOR: MMI-467
Drug: MMI-467
Micro implant monthly x 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure rates
Time Frame: 48 weeks
Based on clinical evaluations (nail measurements, KOH, and mycological culture for dermatophytes), cure categories will be defined as either mycological cure, clinical cure, complete cure, or effective treatment.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talima Therapeutics, Inc.

Investigators

  • Principal Investigator: Terry Jones, MD, J&S Studies, Inc.
  • Principal Investigator: Michael Noss, MD, Radiant Research, Inc.
  • Principal Investigator: Stacy Smith, MD, Therapeutics Clinical Research
  • Principal Investigator: Norman Bystol, MD, Radiant Research, Inc.
  • Principal Investigator: Jose Mendez, DO, International Dermatology Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ANTICIPATED)

April 1, 2011

Study Registration Dates

First Submitted

March 23, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (ESTIMATE)

March 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCP-TMI-7007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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