Tinea Unguium, OnychomycosisPhase 2NCT04341402
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
A Phase 2 study testing Antifungal Nail Gel Study in people with Tinea Unguium, Onychomycosis, run by William N Handelman at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Tinea Unguium, Onychomycosis
- What is being tested?
- Antifungal Nail Gel Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 1 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bay Area Medical
St. Petersburg, Florida, 33710
William N Handelman, 727-384-6411, whandelm@tampabay.rr.com
Myung-Joo Handelman, 7273846411, mhandelman@cancareclinic.com
About this study
Official title: Dr. Bill Antifungal Nail Gel Study
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
Read the 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
- Conditions
- Tinea Unguium, Onychomycosis
- Being tested
- Antifungal Nail Gel Study
- Keywords
- Toenail fungus
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antifungal Nail Gel StudyDrug
Also called drug: diclofenac sodium, drug: miconazole, drug: urea
Daily Application antifungal gel of miconazole 3% and diclofenac sodium 1% and urea 40% to infected nails.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | miconazole 3% \& diclofenac sodium 1% \& urea 40% in topical gel daily for 6 months. Receives: Drug: Antifungal Nail Gel Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diclofenac sodium serum levels
Peak Plasma Concentration (Cmax) diclofenac sodium 12 hours after 1st dose
Measured: 12 hours
Secondary outcomes (1)
Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application
Peak Plasma Concentration (Cmax) of diclofenac sodium
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea Unguium, OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William N Handelman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, William N Handelman, Bay Area Medical
- Investigators
- William N Handelman, MD, Principal investigator, Bay Area Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341402
- Sponsor's protocol ID
- IORG0010258
- Status last verified
- Apr 2020
- First submitted
- 8 Feb 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dr. Bill Antifungal Nail Gel Study
- ClinicalTrials.gov ID
- NCT04341402
- Acronym / sponsor ID
- IORG0010258
- Conditions
- Tinea Unguium, Onychomycosis
- Keywords
- Toenail fungus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- William N HandelmanUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Antifungal Nail Gel Studymiconazole 3% \& diclofenac sodium 1% \& urea 40% in topical gel daily for 6 months. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antifungal Nail Gel StudyAlso: drug: diclofenac sodium, drug: miconazole, drug: ureaDaily Application antifungal gel of miconazole 3% and diclofenac sodium 1% and urea 40% to infected nails. | Drug | Experimental |
Primary outcome
Diclofenac sodium serum levels
Time frame: 12 hours
Peak Plasma Concentration (Cmax) diclofenac sodium 12 hours after 1st dose
1 secondary outcome
Peak Plasma Concentration (Cmax) of diclofenac sodium 3 months after starting application
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William N Handelman, MD principal investigator
Bay Area Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antifungal Nail Gel Study in people with Tinea Unguium, Onychomycosis, run by William N Handelman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William N Handelman, MD (7273846411, whandelm@tampabay.rr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diclofenac sodium serum levels (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.