Clinical trial NCT01093118: A Study to Evaluate TMI-358 in the Treatment of Distal Subungual Onychomycosis
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Distal Subungual Onychomycosis
Keywords: Distal subungual onychomycosis
Lead sponsor: Talima Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Cure rates
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Radiant Research, Inc.
state: Arizona
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Miami
country: United States
facility: International Dermatology Research Center
state: Florida
city: Cincinnati
country: United States
facility: Radiant Research, Inc.
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
Study officials:
affiliation: J&S Studies, Inc.
name: Terry Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Inc.
name: Michael Noss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Medical Research Center
name: Robert Matheson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Center
name: Leonard Swinyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Therapeutics Clinical Research
name: Stacy Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiant Research, Inc.
name: Norman Bystol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Dermatology Research Center
name: Jose Mendez, DO
role: PRINCIPAL_INVESTIGATOR
References: