OnychomycosisPhase 1NCT05578950
Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis
A Phase 1 study testing itraconazole and terbinafine in people with Onychomycosis, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
Trial summary
Nail fungus, often known as onychomycosis (OM), can attack either the toenails or the fingernails. Onychomycosis can affect the matrix, the nail bed, or the nail plate. Though not fatal, onychomycosis is a significant condition that can impede a person's mobility and ability to work. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- itraconazole and terbinafine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2022to 31 Aug 2022
- Phase
- Phase 1
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients age between 18 and 60 years
- patients positive for fungus via direct microscopy due to identification of hyphae or blastospores on the toe nails
- patients having positive fungal culture
- patients who had not applied any topical agent to the target toe nail for the last one month
Who cannot join
- Pregnant patients
- Lactating women
- Patients with poor adherence
- Patients previously allergic to oral itraconazole or terbinafine
- Patients with elevated baseline LFTs such as ALT ,AST , alkaline phosphatase and total bilirubin twice the upper limit of normal
- History of renal disease
Show all 10Show fewer
- Patients unresponsive to systemic antifungal therapy with in the past year
- History of using systemic immunosuppressants
- Immunocompromised patients
- Pateints with ventricular dysfunction and history of congestive heart failure
Trial locations and contacts
1 site in 1 country.
About this study
Nail fungus, often known as onychomycosis (OM), can attack either the toenails or the fingernails. Onychomycosis can affect the matrix, the nail bed, or the nail plate. Though not fatal, onychomycosis is a significant condition that can impede a person's mobility and ability to work. Onychomycosis's wide-ranging emotional and social impacts can have a serious negative impact on patients' well-being.
White superficial onychomycosis (WSO), proximal subungual onychomycosis (PSO), endonyx onychomycosis (EO), and candidal onychomycosis are the most common subtypes of onychomycosis. A patient may exhibit characteristics from more than one of these categories. A severe case of onychomycosis, regardless of its subtype, is called total dystrophic onychomycosis.
Read more
Different types of onychomycosis have different pathophysiology. The most frequent type of onychomycosis, known as distal lateral subungual onychomycosis, occurs when a fungus travels from the plantar skin to the nail bed through the hyponychium.
These sections of the nail apparatus become inflamed, leading to the outward manifestations of distal lateral subungual onychomycosis. White superficial onychomycosis, on the other hand, is a less common presentation produced by invasion of the nail plate's surface. Fungi colonise the deep section of the proximal nail plate in the rare condition known as proximal subungual onychomycosis. When the fungi infect the nail through the skin and penetrate the nail plate, the result is known as endonyx onychomycosis, a subtype of distal lateral onychomycosis.
Over and over again, terbinafine has been shown to be more effective than other antifungal medicines in clinical trials. Mycological cure rates for onychomycosis were 76% with terbinafine, 63% with pulse itraconazole, and 48% with fluconazole, according to a meta-analysis of 18 studies.
The aim of this study is to determine the aim of this study is to compare pulse therapy with oral itraconazole versus continuous oral terbinafine for treatment of onychomycosis
- Conditions
- Onychomycosis
- Being tested
- itraconazole, terbinafine
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itraconazoleDrug
Also called capsules icon
100 mg two capsules of itraconazole were givev twice daily to 50 patients in group A for one week per month . baseline LFTs were also monitered
terbinafineDrug
Also called tablets terbesil
one 250 mg tablet of terbinafine were given once daily to 50 patients in group B for 12 weeks continously
| Study group | Role | What they receive |
|---|---|---|
| group A pulse therapy of itraconazole | Active comparator | patients with pulse therapy group recieved oral itraconazole 100 mg, two capsules twice daily for 7 days a month Receives: Drug: itraconazole |
| group B continous therapy of terbinafine | Active comparator | patients with continous therapy group , recieved continous oral 250 mg terbinafine once daily for 12 weeks continously Receives: Drug: terbinafine |
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of pulse therapy of itraconazole and continuous therapy of terbinafine for the treatment of onychomycosis as assessed by ONYCHOMYCOSIS SEVERITY INDEX (OSI)
OSI is calculated as follows:score of area involvement multiplied by score for proximity of disease to the matrix and10 points are added for the presence of dermatophytoma or subungal hyperkeratosis of greater than 2 mm.
A cumulative score of 0 indicates cured; 1 through 5, mild onychomycosis; 6 through 15, moderate onychomycosis; and 16 through 35 , severe onychomycosis.
Area of involvement score 0 to 5, proximity of disease to matrix score 1 to 5 , presence of subungal dermatophytoma or subungal hyperkeratosis score 0 or 10
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Mar 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Abbottabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mahboob Ali, Combined Military Hospital Abbottabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578950
- Sponsor's protocol ID
- cmh abbottabod
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis
- ClinicalTrials.gov ID
- NCT05578950
- Acronym / sponsor ID
- cmh abbottabod
- Conditions
- Onychomycosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Combined Military Hospital AbbottabadUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 13 Oct 2022 (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.
Nail fungus, often known as onychomycosis (OM), can attack either the toenails or the fingernails. Onychomycosis can affect the matrix, the nail bed, or the nail plate. Though not fatal, onychomycosis is a significant condition that can impede a person's mobility and ability to work. Onychomycosis's wide-ranging emotional and social impacts can have a serious negative impact on patients' well-being.
White superficial onychomycosis (WSO), proximal subungual onychomycosis (PSO), endonyx onychomycosis (EO), and candidal onychomycosis are the most common subtypes of onychomycosis. A patient may exhibit characteristics from more than one of these categories. A severe case of onychomycosis, regardless of its subtype, is called total dystrophic onychomycosis.
Different types of onychomycosis have different pathophysiology. The most frequent type of onychomycosis, known as distal lateral subungual onychomycosis, occurs when a fungus travels from the plantar skin to the nail bed through the hyponychium.
These sections of the nail apparatus become inflamed, leading to the outward manifestations of distal lateral subungual onychomycosis. White superficial onychomycosis, on the other hand, is a less common presentation produced by invasion of the nail plate's surface. Fungi colonise the deep section of the proximal nail plate in the rare condition known as proximal subungual onychomycosis. When the fungi infect the nail through the skin and penetrate the nail plate, the result is known as endonyx onychomycosis, a subtype of distal lateral onychomycosis.
Over and over again, terbinafine has been shown to be more effective than other antifungal medicines in clinical trials. Mycological cure rates for onychomycosis were 76% with terbinafine, 63% with pulse itraconazole, and 48% with fluconazole, according to a meta-analysis of 18 studies.
The aim of this study is to determine the aim of this study is to compare pulse therapy with oral itraconazole versus continuous oral terbinafine for treatment of onychomycosis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A pulse therapy of itraconazole | Active comparator | Drug: itraconazolepatients with pulse therapy group recieved oral itraconazole 100 mg, two capsules twice daily for 7 days a month |
| group B continous therapy of terbinafine | Active comparator | Drug: terbinafinepatients with continous therapy group , recieved continous oral 250 mg terbinafine once daily for 12 weeks continously |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients age between 18 and 60 years
- patients positive for fungus via direct microscopy due to identification of hyphae or blastospores on the toe nails
- patients having positive fungal culture
- patients who had not applied any topical agent to the target toe nail for the last one month
Key exclusion criteria (10 listed)
- Pregnant patients
- Lactating women
- Patients with poor adherence
- Patients previously allergic to oral itraconazole or terbinafine
- Patients with elevated baseline LFTs such as ALT ,AST , alkaline phosphatase and total bilirubin twice the upper limit of normal
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 |
|---|---|---|
| itraconazoleAlso: capsules icon100 mg two capsules of itraconazole were givev twice daily to 50 patients in group A for one week per month . baseline LFTs were also monitered | Drug | group A pulse therapy of itraconazole |
| terbinafineAlso: tablets terbesilone 250 mg tablet of terbinafine were given once daily to 50 patients in group B for 12 weeks continously | Drug | group B continous therapy of terbinafine |
Primary outcome
effectiveness of pulse therapy of itraconazole and continuous therapy of terbinafine for the treatment of onychomycosis as assessed by ONYCHOMYCOSIS SEVERITY INDEX (OSI)
Time frame: 12 weeks
OSI is calculated as follows:score of area involvement multiplied by score for proximity of disease to the matrix and10 points are added for the presence of dermatophytoma or subungal hyperkeratosis of greater than 2 mm. A cumulative score of 0 indicates cured; 1 through 5, mild onychomycosis; 6 through 15, moderate onychomycosis; and 16 through 35 , severe onychomycosis. Area of involvement score 0 to 5, proximity of disease to matrix score 1 to 5 , presence of subungal dermatophytoma or subungal hyperkeratosis score 0 or 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing itraconazole and terbinafine in people with Onychomycosis, run by Combined Military Hospital Abbottabad at 1 site in Pakistan.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 19 Oct 2022. 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 Pakistan. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of pulse therapy of itraconazole and continuous therapy of terbinafine for the treatment of onychomycosis as assessed by ONYCHOMYCOSIS SEVERITY INDEX (OSI) (time frame: 12 weeks). 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 19 Oct 2022.