NCT01093118TerminatedPhase 2
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 enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Talima Therapeutics, Inc.
- Enrollment
- 120
- Locations
- 6
- Primary Endpoint
- Cure rates
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Active treatment
Intervention: TMI-358 (Drug)
MMI-467
Placebo Comparator
Intervention: MMI-467 (Drug)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
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