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NCT Number: NCT03168841

Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients

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

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Western University of Health Sciences

Pomona, California, 91711, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Efinaconazole Topical

Drug

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

Primary outcomes

  1. Primary Endpoint - Efficacy

    Time frame: 50 weeks

    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).

Secondary outcomes

  1. Secondary Endpoint - Efficacy

    Time frame: 50 weeks

    The first secondary efficacy end point is mycological cure, defined as negative KOH examination and negative fungal culture of the target toenail sample.

  2. Secondary Endpoint - Efficacy

    Time frame: 50 weeks

    The second secondary efficacy end point is clinical cure, defined as 0% clinical involvement of the target toenail.

  3. Secondary Endpoint - Safety (Occurrence of Adverse Events: Type and Frequency)

    Time frame: 50 weeks

    The secondary safety endpoint is the occurrence of adverse events (type and frequency).

Sponsors and collaborators

Lead sponsor

Western University of Health Sciences

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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