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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03168841
Other study ID # 2014-26
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 6, 2017
Est. completion date January 9, 2019

Study information

Verified date October 2020
Source Western University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Onychomycosis, a common pathology of the toenails, is even more prevalent among diabetic subjects. Nearly 26 million Americans suffer from diabetes, and approximately one-third of subjects with diabetes have toenail onychomycosis. Numerous studies have addressed the efficacy and safety of both topical and oral antifungal treatment options for onychomycosis in diabetic subjects. However, no study to date has specifically addressed the efficacy and safety of efinaconazole among diabetic subjects. The objective of this noncomparative, uncontrolled study is to determine the efficacy of topical efinaconazole 10% for toenail onychomycosis among subjects with diabetes mellitus. Specific indicators to measure efficacy of treatment will be the mycological cure rate, complete cure rate, and treatment success. Furthermore, an additional goal of the study is to gain knowledge of safety in the setting of a cohort of diabetic subjects


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 9, 2019
Est. primary completion date January 9, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of onychomycosis confirmed through positive KOH stain or positive mycologic culture findings. - Involvement of at minimum 20% of the target great toenail. Exclusion Criteria: - Diagnosis of a nondermatophyte fungus infection, diagnosis of proximal subungual onychomycosis, diagnosis of superficial white onychomycosis - Diagnosis of peripheral arterial disease or anatomic abnormalities of the target toenail - Inability to follow through with all requisite office visits - Routine use of a systemic corticosteroid, routine use of a systemic immunomodulator, or history of systemic antifungals within the prior five years. - Active interdigital tinea pedis refractory to topical antifungal treatments - Known hypersensitivity to efinaconazole - Use, within the month preceding screening, of: topical antifungal agents, topical anti-inflammatory agents to the toes - Any history of oral systemic antifungal with known activity against dermatophytes

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Efinaconazole Topical
Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.

Locations

Country Name City State
United States Western University of Health Sciences Pomona California

Sponsors (1)

Lead Sponsor Collaborator
Western University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Endpoint - Efficacy The primary efficacy end point is the proportion of subjects achieving complete cure at week 50. Complete cure is to be defined as a combination of 0% clinical involvement and mycological cure (mycological cure defined as negative KOH examination and negative fungal culture of the target toenail sample). 50 weeks
Secondary Secondary Endpoint - Efficacy The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample. 50 weeks
Secondary Secondary Endpoint - Efficacy The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail. 50 weeks
Secondary Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency) The secondary safety endpoint is the occurrence of adverse events (type and frequency). 50 weeks
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