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

Talima Therapeutics, Inc.6 sites in 1 country120 target enrollmentSeptember 2009

ConditionsDistal Subungual Onychomycosis

InterventionsTMI-358 MMI-467

DrugsTMI-358 MMI-467

Overview

Phase: Phase 2
Intervention: TMI-358
Conditions: Distal Subungual Onychomycosis
Sponsor: Talima Therapeutics, Inc.
Enrollment: 120
Locations: 6
Primary Endpoint: Cure rates
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

April 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Talima Therapeutics, Inc.

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

Arms & Interventions

TMI-358

Active treatment

Intervention: TMI-358

MMI-467

Intervention: MMI-467

Outcomes

Primary Outcomes

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.