Efficacy and Safety Study of ME1111 in Patients With Onychomycosis (NCT02022215) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety Study of ME1111 in Patients With Onychomycosis
United States304 participantsStarted 2013-12-19
Plain-language summary
The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Mild to moderate distal lateral subungual onychomycosis
* A positive potassium hydroxide (KOH) microscopy
* A positive fungal culture for a dermatophyte
* Good general health
Exclusion Criteria:
* Uncontrolled diabetes
* Onychomycosis of the fingernails
* Prior use of antifungal drugs (Failure to complete the specified washout period)
* History of HIV, Hepatitis B or Hepatitis C
* Diagnosis of psoriasis or history of psoriasis
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Pregnancy/lactation