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

Last updated: April 8, 2020
Sponsor: William N Handelman
Overall Status: Active - Recruiting

Phase

2

Condition

Toenail Fungus (Onychomycosis)

Treatment

N/A

Clinical Study ID

NCT04341402
IORG0010258
  • Ages 21-100
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 clinicalfeatures 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 ofnail with growth of any of the following Dermatophytes, non-dermatophytes or yeast.

  6. TABLE 1 Epidermophyton floccosum Trichophyton mentagrophytes Trichophyton rubrumAcremonium Alternaria species Aspergillus species Botryodiplodia theobromae Fusariumspecies Onycochola canadensis Pyrenochaeta unguis-hominis Scytalidium dimidiatumscopulariopsis species Scytalidium hyalimum Candida albicans

Exclusion

Exclusion Criteria:

  1. Chronic renal failure, chronic liver disease, alcoholism, pregnant, breastfeeding, orunwilling to practice birth control during participation in the study if ofchildbearing age..

  2. Presence of a condition or abnormality that in the opinion of the Investigator wouldcompromise the safety of the patient or the quality of the data.

  3. Concomitant use of any prescribed medication that may be adversely affected bydiclofenac sodium.

Study Design

Total Participants: 30
Study Start date:
May 01, 2020
Estimated Completion Date:
May 01, 2021

Study 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

Connect with a study center

  • Bay Area Medical

    Saint Petersburg, Florida 33710
    United States

    Active - Recruiting

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