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

Phase 2

Terminated

• Conditions: Distal Subungual Onychomycosis
• Interventions: Drug: TMI-358; Drug: MMI-467

• Registration Number: NCT01093118
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-14
• Last Update Posted: 2011-01-17
• Primary Completion: 2011-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TMI-358	TMI-358	Active treatment
MMI-467	MMI-467	-

Primary Outcome Measures

Name	Time	Method
Cure rates	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.

Trial Locations

Locations (6)

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

International Dermatology Research Center; 🇺🇸 Miami, Florida, United States

J&S Studies, Inc.; 🇺🇸 College Station, Texas, United States

Dermatology Research Center; 🇺🇸 Salt Lake City, Utah, United States

Radiant Research, Inc.; 🇺🇸 Cincinnati, Ohio, United States

Oregon Medical Research Center; 🇺🇸 Portland, Oregon, United States