A Study to Evaluate TMI-358 in the Treatment of Distal Subungual Onychomycosis
NCT ID: NCT01093118
Last Updated: 2011-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
120 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TMI-358
Active treatment
TMI-358
Micro implant monthly x 3
MMI-467
MMI-467
Micro implant monthly x 3
Interventions
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TMI-358
Micro implant monthly x 3
MMI-467
Micro implant monthly x 3
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Talima Therapeutics, Inc.
INDUSTRY
Responsible Party
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Talima Therapeutics, Inc.
Principal Investigators
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Terry Jones, MD
Role: PRINCIPAL_INVESTIGATOR
J&S Studies, Inc.
Michael Noss, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Inc.
Robert Matheson, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Medical Research Center
Leonard Swinyer, MD
Role: PRINCIPAL_INVESTIGATOR
Dermatology Research Center
Stacy Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Therapeutics Clinical Research
Norman Bystol, MD
Role: PRINCIPAL_INVESTIGATOR
Radiant Research, Inc.
Jose Mendez, DO
Role: PRINCIPAL_INVESTIGATOR
International Dermatology Research Center
Locations
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Radiant Research, Inc.
Tucson, Arizona, United States
Therapeutics Clinical Research
San Diego, California, United States
International Dermatology Research Center
Miami, Florida, United States
Radiant Research, Inc.
Cincinnati, Ohio, United States
Oregon Medical Research Center
Portland, Oregon, United States
J&S Studies, Inc.
College Station, Texas, United States
Dermatology Research Center
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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TCP-TMI-7007
Identifier Type: -
Identifier Source: org_study_id
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