Onychomycosis
Conditions
Interventions
investigational material(s)
Generic name etc : ME1111 solution
INN of investigational material : -
Therapeutic category code : 629 Other chemotherapeutics
Dosage and Administration for Investigational
Sponsors
Meiji Seika Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: >Mild to moderate onychomycosis who meet all of the following criteria -At least one great toenail (target great toenail = TGT) affected which has 20 to 50% involvement -No more than 6 involved toenails in total, as determined by visual inspection >A positive KOH microscopy test result of the TGT and fungal culture for a dermatophyte from the TGT at Screening
Exclusion criteria
Exclusion criteria: >History of allergy to any components of the solution product (including alcohol) >Presence of any underlying disease that the investigator seems uncontrolled and poses a concern for the subject's safety while participating on the study; e.g., cardiovascular disease, liver disease, pulmonary disease, blood disease, etc. >Presence of diabetes mellitus that is uncontrolled as determined by the Investigator, or HbA1c >= 7.0% >Subject who received systemic antifungals drugs, topical antifungal drugs, laser and any other therapies for onychomycosis within 24 weeks prior to administration of drug >Subject who couldn't obtain the effect expected in onychomycosis treatment by antifungals drugs in the past >Unwilling to refrain from the use of topical antifungal drugs for treatment of tinea pedis >Nail or anatomic abnormalities of the toe that may interfere with the evaluation of the study drug, as determined by investigators , e.g. genetic nail disorders, pigmentary disorders, onychogryphosis, trauma to the nail(s) >Subjects who are unable to apply the study drug >Presence of psoriasis or history of psoriasis >Subjects with chronic moccasin type tinea pedis >Presence of immunodeficiencies (including HIV) >Females who are nursing, pregnant, or planning a pregnancy during the study or males who plans to have their partners get pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Complete cure at Week 52/End of study Mycology assessments, Asses the affected nail area of the TGT | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -Complete cure or almost complete cure at Week 52/End of study -Adverse Events -Mycology assessments, Asses the affected nail area of the TGT -Incidence of adverse events. | — |
Countries
Japan
Outcome results
None listed