Status:
UNKNOWN
Systemic Uptake of Diclofenac Sodium in Combination With Miconazole as Antifungal Nail Gel When Applied Daily With Monitoring of Hepatic and Renal Enzymes, and Serum Levels of Diclofenac 12 Hours After Application, and at 3 and 6 Months Study
Lead Sponsor:
William N Handelman
Conditions:
Tinea Unguium, Onychomycosis
Eligibility:
All Genders
21-100 years
Phase:
PHASE2
Brief Summary
Study evaluates these take of diclofenac sodium when used in conjunction with miconazole and urea as a topical antifungal nail gel treatment for onychomycosis. All of the patient's will be treated wit...
Detailed Description
Tinea Unguium/onychomycosis is a ubiquitous health problem affecting \~3% of the adult population. It is associated with higher risk for other disease processes. Effective treatment for this disease h...
Eligibility Criteria
Inclusion
- Male or female ≥ 21 years of age at Visit 1.
- Not pregnant.
- Stage 3 or lower Chronic Renal Failure.
- PT/INR \< 1.3 and not on anti-thrombotic; AST, ALT, Total Bilirubin WNL.
- Documentation of a diagnosis of tinea unguium as evidenced by one or more clinical features consistent with the onychomycosis and one or more of the following criteria: KOH prep of the nail scrapings or positive culture of the nail scrapings; culture of nail with growth of any of the following Dermatophytes, non-dermatophytes or yeast.
- TABLE 1 Epidermophyton floccosum Trichophyton mentagrophytes Trichophyton rubrum Acremonium Alternaria species Aspergillus species Botryodiplodia theobromae Fusarium species Onycochola canadensis Pyrenochaeta unguis-hominis Scytalidium dimidiatum scopulariopsis species Scytalidium hyalimum Candida albicans
Exclusion
- Chronic renal failure, chronic liver disease, alcoholism, pregnant, breastfeeding, or unwilling to practice birth control during participation in the study if of childbearing age..
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Concomitant use of any prescribed medication that may be adversely affected by diclofenac sodium.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04341402
Start Date
May 1 2020
End Date
May 1 2021
Last Update
April 10 2020
Active Locations (1)
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1
Bay Area Medical
St. Petersburg, Florida, United States, 33710