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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04341402
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Information provided by (Responsible Party):
William N Handelman, Bay Area Medical

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

Condition or disease Intervention/treatment Phase
Tinea Unguium, Onychomycosis Drug: Antifungal Nail Gel Study Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dr. Bill Antifungal Nail Gel Study
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental
miconazole 3% & diclofenac sodium 1% & urea 40% in topical gel daily for 6 months.
Drug: Antifungal Nail Gel Study
Daily Application antifungal gel of miconazole 3% and diclofenac sodium 1% and urea 40% to infected nails.
Other Names:
  • drug: diclofenac sodium
  • drug: miconazole
  • drug: urea

Primary Outcome Measures :
  1. Diclofenac sodium serum levels [ Time Frame: 12 hours ]
    Peak Plasma Concentration (Cmax) diclofenac sodium 12 hours after 1st dose

Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application [ Time Frame: 3 months ]
    Peak Plasma Concentration (Cmax) of diclofenac sodium

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04341402

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Contact: William N Handelman, MD 7273846411
Contact: Myung-Joo Handelman, ARNP 7273846411

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United States, Florida
Bay Area Medical Recruiting
Saint Petersburg, Florida, United States, 33710
Contact: William N Handelman    727-384-6411   
Contact: Myung-Joo Handelman    7273846411   
Sponsors and Collaborators
William N Handelman
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Principal Investigator: William N Handelman, MD Bay Area Medical
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Responsible Party: William N Handelman, Principal Investigator, Bay Area Medical Identifier: NCT04341402    
Other Study ID Numbers: IORG0010258
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by William N Handelman, Bay Area Medical:
Toenail fungus
Additional relevant MeSH terms:
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Bacterial Infections and Mycoses
Skin Diseases, Infectious
Nail Diseases
Skin Diseases
Antifungal Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists