Clinical trial NCT04341402: 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
Official title: Dr. Bill Antifungal Nail Gel Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tinea Unguium, Onychomycosis
Keywords: Toenail fungus
Lead sponsor: Bay Area Medical
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 with the active formula and blood levels of diclofenac sodium tested for as well as monitoring of hepatic and renal functions

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 has been lacking. Oral antifungal agents are associated with high incidence of recurrence of disease, hepatotoxicity, cytochrome P450 Pathway interference, non-compliance, side effects and cost. No effective long-term topical applications have been verified. Debridement of the damaged nail in combination with a broad-spectrum topical antifungal agent and an anti-inflammatory agent is a safe, inexpensive and easily formulated alternative to previous ineffective treatments. The rationale for debridement is simple in that the effectiveness of the topical antifungal is present only when it is in contact with the fungal agent, nail bed and involved diseased tissue. The associated inflammatory response associated with fungal infections is well-established. The only topical NSAID available in the United States is diclofenac sodium. The combination of miconazole, diclofenac sodium and urea has proven effective in this researcher's self-treatment of tinea unguium. Miconazole and diclofenac sodium are well studied and well-established pharmaceutical

Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 21 years of age at Visit 1.
2. Not pregnant.
3. Stage 3 or lower Chronic Renal Failure.
4. PT/INR \< 1.3 and not on anti-thrombotic; AST, ALT, Total Bilirubin WNL.
5. 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.
6. 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 Criteria:

1. Chronic renal failure, chronic liver disease, alcoholism, pregnant, breastfeeding, or unwilling to practice birth control during participation in the study if of childbearing age..
2. 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.
3. Concomitant use of any prescribed medication that may be adversely affected by diclofenac sodium.

Primary outcomes:
measure: Diclofenac sodium serum levels
timeFrame: 12 hours
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Bay Area Medical
state: Florida
Study officials:
affiliation: Bay Area Medical
name: William N Handelman, MD
role: PRINCIPAL_INVESTIGATOR
References: