The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

• IDP-108 (Drug): Topical application once a day for 48 weeks
• Vehicle (Drug): Topical application once a day for 48 weeks

Primary outcomes

• Percentage of patients who achieve clinical cure [52 weeks]

Secondary outcomes

• Percentage of patients who achieve clinical efficacy [52 weeks]
• Percentage of patients who achieve mycologic cure [52 weeks]

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Clinically diagnosed onychomycosis of the target nail
* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
* Has a positive KOH examination from the target nail
* Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

• Results publication: Gupta AK, Elewski BE, Sugarman JL, Ieda C, Kawabata H, Kang R, Pillai R, Olin JT, Watanabe S. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014 Jul;13(7):815-20. PMID 25007364