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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

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ClinicalTrials.gov Identifier: NCT04341402
Recruitment Status : Recruiting
First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
William N Handelman, Bay Area Medical

Tracking Information
First Submitted Date  ICMJE February 8, 2020
First Posted Date  ICMJE April 10, 2020
Last Update Posted Date April 10, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
Diclofenac sodium serum levels [ Time Frame: 12 hours ]
Peak Plasma Concentration (Cmax) diclofenac sodium 12 hours after 1st dose
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application [ Time Frame: 3 months ]
Peak Plasma Concentration (Cmax) of diclofenac sodium
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Dr. Bill Antifungal Nail Gel Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tinea Unguium, Onychomycosis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Experimental
miconazole 3% & diclofenac sodium 1% & urea 40% in topical gel daily for 6 months.
Intervention: Drug: Antifungal Nail Gel Study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: William N Handelman, MD 7273846411 whandelm@tampabay.rr.com
Contact: Myung-Joo Handelman, ARNP 7273846411 mhandelman@cancareclinic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04341402
Other Study ID Numbers  ICMJE IORG0010258
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party William N Handelman, Bay Area Medical
Study Sponsor  ICMJE William N Handelman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William N Handelman, MD Bay Area Medical
PRS Account Bay Area Medical
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP