Dermatophyte InfectionPhase 2NCT06680544
Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections
A Phase 2 study testing Voriconazole high dose and Voriconazole low dose in people with Dermatophyte Infection, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial summary
Treatment of dermatophyte infection in our country (Pakistan) is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness ,feasibility and standard dosage of a newer antifungal drug like voriconazole is the need of the hour in resistant cases of dermatophyte… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dermatophyte Infection
- What is being tested?
- Voriconazole high dose and Voriconazole low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2024to 15 Mar 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Resistant cases of tinea cruris and tinea corporis: Those cases who received the standard dosage of oral antifungals i.e. oral terbinafine 5mg/kg per day for 4 weeks or oral itraconazole 5mg per/kg/day for 4 weeks but they did not recover from the infection.
- Skin area: Groin and trunk
- Total diameter of the lesions: 5cm to 80 cm
Who cannot join
- History of hypersensitivity to azoles
- All those individuals having immunocompromised state (malignancy, tuberculosis, AIDS, history of organ transplant and history of immunosuppressive drug treatment etc.)
- Patients of diabetes, liver or kidney disease.
- Lactating mother
- Pregnant female
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Sheikh zayed Medical College and Hospital
Rahim Yar Khan, Punjab Province, 64200
Sheikh zayed Medical college SZMC/H, +92689230168, info@szmc.edu.pk
About this study
Official title: Comparing the Efficacy of Oral 200 Milligram Voriconazole Once a Day Vs. Twice a Day in the Treatment of Resisitant Dermatophyte Infections (Tinea Corporis and Tinea Cruris)
Treatment of dermatophyte infection in our country (Pakistan) is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness ,feasibility and standard dosage of a newer antifungal drug like voriconazole is the need of the hour in resistant cases of dermatophyte infection.
Read the detailed description
Treatment of dermatophyte infection in our country is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness and feasibility of a newer antifungal drug like voriconazole is the need of the hour in resistant cases.
Objective: To compare the efficacy of oral 200 milligram voriconazole once a day vs twice a day in the treatment of resistant dermatophyte infections (tinea corporis and cruris).
Material \& Methods: This randomized controlled trial using non-probability sampling technique will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval from ethical review committee of the hospital has been taken. Total 106 patients will be divided into two groups, Group A and Group B, each consisting of 53 patients. Group A will be given oral voriconazole 200mg once a day and Group B will be given twice a day for a maximum of 28 days. Efficacy will be assessed at day 14 and day 28, and relapse will be noted at the 2-month follow-up visit. Data will be recorded on a preformed Proforma for each patient and wiil be analyzed using SPSS 24. A p-value of less than 0.05 will be considered statistically significant.
- Conditions
- Dermatophyte Infection
- Being tested
- Voriconazole high dose, Voriconazole low dose
- Keywords
- Tinea, Voriconazole, Dermatomycoses, Antifungal Agents
- Medical subject headings
- Dermatomycoses, Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voriconazole high doseDrug
Oral voriconazole 200mg once a day for a maximum of 28 days
Voriconazole low doseDrug
Oral voriconazole 200mg twice a day for a maximum of 28 days
| Study group | Role | What they receive |
|---|---|---|
| oral voriconazole 200 mg once daily group (group A) | Active comparator | Patients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg once daily Receives: Drug: Voriconazole low dose |
| oral voriconazole 200 mg twice daily group (group B) | Active comparator | Patients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg twice daily Receives: Drug: Voriconazole high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of oral voriconazole 200 mg once daily(low dose) vs. twice daily (high dose)
Efficacy will be assesssed clinically either through complete resolution of lesion or leaving behind pigmentation
Measured: Clinical assessment for efficacy will be done at day 14 and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatophyte InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Khurram Shahzad, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06680544
- Sponsor's protocol ID
- SZMC/H
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Oral 200 Milligram Voriconazole Once a Day Vs. Twice a Day in the Treatment of Resisitant Dermatophyte Infections (Tinea Corporis and Tinea Cruris)
- ClinicalTrials.gov ID
- NCT06680544
- Acronym / sponsor ID
- SZMC/H
- Conditions
- Dermatophyte Infection
- Keywords
- Tinea, Voriconazole, Dermatomycoses, Antifungal Agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 8 Nov 2024 (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.
Treatment of dermatophyte infection in our country (Pakistan) is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness ,feasibility and standard dosage of a newer antifungal drug like voriconazole is the need of the hour in resistant cases of dermatophyte infection.
Detailed description
Treatment of dermatophyte infection in our country is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness and feasibility of a newer antifungal drug like voriconazole is the need of the hour in resistant cases.
Objective: To compare the efficacy of oral 200 milligram voriconazole once a day vs twice a day in the treatment of resistant dermatophyte infections (tinea corporis and cruris).
Material \& Methods: This randomized controlled trial using non-probability sampling technique will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval from ethical review committee of the hospital has been taken. Total 106 patients will be divided into two groups, Group A and Group B, each consisting of 53 patients. Group A will be given oral voriconazole 200mg once a day and Group B will be given twice a day for a maximum of 28 days. Efficacy will be assessed at day 14 and day 28, and relapse will be noted at the 2-month follow-up visit. Data will be recorded on a preformed Proforma for each patient and wiil be analyzed using SPSS 24. A p-value of less than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral voriconazole 200 mg once daily group (group A) | Active comparator | Drug: Voriconazole low dosePatients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg once daily |
| oral voriconazole 200 mg twice daily group (group B) | Active comparator | Drug: Voriconazole high dosePatients with resistant dermatophyte infection (tinea corporis and cruris)will be given oral voriconazole 200 mg twice daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Resistant cases of tinea cruris and tinea corporis: Those cases who received the standard dosage of oral antifungals i.e. oral terbinafine 5mg/kg per day for 4 weeks or oral itraconazole 5mg per/kg/day for 4 weeks but they did not recover from the infection.
- Skin area: Groin and trunk
- Total diameter of the lesions: 5cm to 80 cm
Key exclusion criteria (5 listed)
- History of hypersensitivity to azoles
- All those individuals having immunocompromised state (malignancy, tuberculosis, AIDS, history of organ transplant and history of immunosuppressive drug treatment etc.)
- Patients of diabetes, liver or kidney disease.
- Lactating mother
- Pregnant female
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 |
|---|---|---|
| Voriconazole high doseOral voriconazole 200mg once a day for a maximum of 28 days | Drug | oral voriconazole 200 mg twice daily group (group B) |
| Voriconazole low doseOral voriconazole 200mg twice a day for a maximum of 28 days | Drug | oral voriconazole 200 mg once daily group (group A) |
Primary outcome
Efficacy of oral voriconazole 200 mg once daily(low dose) vs. twice daily (high dose)
Time frame: Clinical assessment for efficacy will be done at day 14 and day 28
Efficacy will be assesssed clinically either through complete resolution of lesion or leaving behind pigmentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 Voriconazole high dose and Voriconazole low dose in people with Dermatophyte Infection, run by Sheikh Zayed Medical College 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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Nov 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Khurram Shahzad, FCPS dermatology (+923354847957, dr.khuram178@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of oral voriconazole 200 mg once daily(low dose) vs. twice daily (high dose) (time frame: Clinical assessment for efficacy will be done at day 14 and day 28). 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 8 Nov 2024.