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

Distal Subungual Onychomycosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01093118
• Other study ID #: TCP-TMI-7007
• Status: Terminated
• Phase: Phase 2
• First received: March 23, 2010
• Last updated: January 14, 2011
• Start date: September 2009

Study information

• Verified date: January 2011
• Source: Talima Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Subungual Onychomycosis
• Onychomycosis

Intervention

Drug:
• TMI-358
Micro implant monthly x 3
• MMI-467
Micro implant monthly x 3

Locations

Country	Name	City	State
United States	Radiant Research, Inc.	Cincinnati	Ohio
United States	J&S Studies, Inc.	College Station	Texas
United States	International Dermatology Research Center	Miami	Florida
United States	Oregon Medical Research Center	Portland	Oregon
United States	Dermatology Research Center	Salt Lake City	Utah
United States	Therapeutics Clinical Research	San Diego	California
United States	Radiant Research, Inc.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Talima Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rates	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.	48 weeks	No