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

Primary Purpose

Distal Subungual Onychomycosis

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

TMI-358

MMI-467

About this trial

This is an interventional treatment trial for Distal Subungual Onychomycosis focused on measuring Distal subungual onychomycosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Radiant Research, Inc.
Therapeutics Clinical Research
International Dermatology Research Center
Radiant Research, Inc.
Oregon Medical Research Center
J&S Studies, Inc.
Dermatology Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TMI-358

MMI-467

Arm Description

Active treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01093118

First Posted

March 23, 2010

Last Updated

January 14, 2011

Sponsor

Talima Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01093118

Brief Title

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

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Terminated

Why Stopped

Business decision

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2011 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Talima Therapeutics, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Distal Subungual Onychomycosis

Keywords

Distal subungual onychomycosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TMI-358

Arm Type

Experimental

Arm Description

Active treatment

Arm Title

MMI-467

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TMI-358

Intervention Description

Micro implant monthly x 3

Intervention Type

Drug

Intervention Name(s)

MMI-467

Intervention Description

Micro implant monthly x 3

Primary Outcome Measure Information:

Title

Cure rates

Description

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials: