ME1111 Phase II (ME1111-3)
- Conditions
- Onychomycosis
- Registration Number
- JPRN-jRCT2080223784
- Lead Sponsor
- Meiji Seika Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 240
>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
>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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Complete cure at Week 52/End of study<br>Mycology assessments, Asses the affected nail area of the TGT
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>-Complete cure or almost complete cure at Week 52/End of study<br>-Adverse Events<br>-Mycology assessments, Asses the affected nail area of the TGT<br>-Incidence of adverse events.