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
Primary Purpose
Tinea Unguium, Onychomycosis
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Antifungal Nail Gel Study
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Unguium, Onychomycosis focused on measuring Toenail fungus
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Bay Area MedicalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
miconazole 3% & diclofenac sodium 1% & urea 40% in topical gel daily for 6 months.
Outcomes
Primary Outcome Measures
Diclofenac sodium serum levels
Peak Plasma Concentration (Cmax) diclofenac sodium 12 hours after 1st dose
Secondary Outcome Measures
Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application
Peak Plasma Concentration (Cmax) of diclofenac sodium
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04341402
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Anticipated)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
William N Handelman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Unguium, Onychomycosis
Keywords
Toenail fungus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
miconazole 3% & diclofenac sodium 1% & urea 40% in topical gel daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
Antifungal Nail Gel Study
Other Intervention Name(s)
drug: diclofenac sodium, drug: miconazole, drug: urea
Intervention Description
Daily Application antifungal gel of miconazole 3% and diclofenac sodium 1% and urea 40% to infected nails.
Primary Outcome Measure Information:
Title
Diclofenac sodium serum levels
Description
Peak Plasma Concentration (Cmax) diclofenac sodium 12 hours after 1st dose
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application
Description
Peak Plasma Concentration (Cmax) of diclofenac sodium
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William N Handelman, MD
Phone
7273846411
Email
whandelm@tampabay.rr.com
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Joo Handelman, ARNP
Phone
7273846411
Email
mhandelman@cancareclinic.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William N Handelman, MD
Organizational Affiliation
Bay Area Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay Area Medical
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William N Handelman
Phone
727-384-6411
Email
whandelm@tampabay.rr.com
First Name & Middle Initial & Last Name & Degree
Myung-Joo Handelman
Phone
7273846411
Email
mhandelman@cancareclinic.com
12. IPD Sharing Statement
Learn more about this trial
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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