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

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: NCT01093118
Recruitment Status : Terminated (Business decision)
First Posted : March 25, 2010
Last Update Posted : January 17, 2011
Information provided by:
Talima Therapeutics, Inc.

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

Condition or disease Intervention/treatment Phase
Distal Subungual Onychomycosis Drug: TMI-358 Drug: MMI-467 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Estimated Primary Completion Date : April 2011

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01093118

United States, Arizona
Radiant Research, Inc.
Tucson, Arizona, United States, 85710
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Florida
International Dermatology Research Center
Miami, Florida, United States, 33144
United States, Ohio
Radiant Research, Inc.
Cincinnati, Ohio, United States, 45249
United States, Oregon
Oregon Medical Research Center
Portland, Oregon, United States, 97223
United States, Texas
J&S Studies, Inc.
College Station, Texas, United States, 77845
United States, Utah
Dermatology Research Center
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Talima Therapeutics, Inc.
Principal Investigator: Terry Jones, MD J&S Studies, Inc.
Principal Investigator: Michael Noss, MD Radiant Research, Inc.
Principal Investigator: Robert Matheson, MD Oregon Medical Research Center
Principal Investigator: Leonard Swinyer, MD Dermatology Research Center
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

Responsible Party: Martin Babler, Talima Therapeutics, Inc. Identifier: NCT01093118     History of Changes
Other Study ID Numbers: TCP-TMI-7007
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: January 17, 2011
Last Verified: January 2011

Keywords provided by Talima Therapeutics, Inc.:
Distal subungual onychomycosis

Additional relevant MeSH terms:
Skin Diseases, Infectious
Nail Diseases
Skin Diseases