NCT01093118

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

January 17, 2011

Status Verified

January 1, 2011

Enrollment Period

1.6 years

First QC Date

March 23, 2010

Last Update Submit

January 14, 2011

Conditions

Distal Subungual Onychomycosis

Keywords

Distal subungual onychomycosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

TMI-358

EXPERIMENTAL

Active treatment

Drug: TMI-358

MMI-467

PLACEBO COMPARATOR
Drug: MMI-467

Interventions

TMI-358DRUG

Micro implant monthly x 3

TMI-358
MMI-467DRUG

Micro implant monthly x 3

MMI-467

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Radiant Research, Inc.

Tucson, Arizona, 85710, United States

Location

Therapeutics Clinical Research

San Diego, California, 92123, United States

Location

International Dermatology Research Center

Miami, Florida, 33144, United States

Location

Radiant Research, Inc.

Cincinnati, Ohio, 45249, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84124, United States

Location

Study Officials

  • Terry Jones, MD

    J&S Studies, Inc.

    PRINCIPAL INVESTIGATOR

  • Michael Noss, MD

    Radiant Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Robert Matheson, MD

    Oregon Medical Research Center

    PRINCIPAL INVESTIGATOR

  • Leonard Swinyer, MD

    Dermatology Research Center

    PRINCIPAL INVESTIGATOR

  • Stacy Smith, MD

    Therapeutics Clinical Research

    PRINCIPAL INVESTIGATOR

  • Norman Bystol, MD

    Radiant Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Jose Mendez, DO

    International Dermatology Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

September 1, 2009

Primary Completion

April 1, 2011

Last Updated

January 17, 2011

Record last verified: 2011-01

Locations

US(7)