Efficacy and Safety of Efinaconazole 10% Solution in the Treatment of Onychomycosis in Diabetic Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Podiatry |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/7/2018 |
| Start Date: | June 6, 2017 |
| End Date: | December 20, 2018 |
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
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
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
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