Pityriasis VersicolorPhase 4NCT06922344
Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor
A Phase 4 study testing Fluconazole and Itraconazole in people with Pityriasis Versicolor, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
This study compares the efficacy of two drugs, namely flucanazole and itraconazole for the treatment of a common fungal infection of skin. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pityriasis Versicolor
- What is being tested?
- Fluconazole and Itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Phase 4
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All cases of Pityriasis versicolor
Who cannot join
- Patients with history of chronic renal or liver disease, malignancy , or undergoing any kind of chemotherapy or radiotherapy or having cardiac conduction abnormalities.
- Patients who received any anti-fungal therapy in the last one month.
- Pregnant or lactating women.
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, 1 recruiting
- Recruiting
Khyber Teaching Hospital
Peshawar, KPK, 25000
Hajira Amin, 0346 9075951, info@kth.edu.pk
About this study
This study compares the efficacy of two drugs, namely flucanazole and itraconazole for the treatment of a common fungal infection of skin.
Read the detailed description
Pityriasis versicolor is a common fungal infection of the superficial skin layers. Avalible treatment options include topical and systemic drugs. fluconazole and itraconazole are commonly used systemic agents. The aim of this study is to compare the efficacy of the two systemic drugs.
- Conditions
- Pityriasis Versicolor
- Being tested
- Fluconazole, Itraconazole
- Keywords
- Pityriasis Versicolor, Fluconazole, Itraconazole
- Medical subject headings
- Tinea Versicolor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
Oral fluconazole prescribed to group A
ItraconazoleDrug
Oral itraconazole prescribed to Group B
| Study group | Role | What they receive |
|---|---|---|
| Group A, Fluconazole group | Experimental | Group A consists of patients in whom oral fluconazole is given in dose of 300mg once weekly for 2 weeks. Receives: Drug: Fluconazole |
| Group B, Itraconazole group | Experimental | Group B consists of patients in whom oral Itraconazole is given in dose of 100mg Twice for 5 days. Receives: Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Treatment
Efficacy of treatment is defined by absence of scaling by naked eye examination ,absence of yellow or golden scale reflection on woods lamp examination and absence of fungal hyphae on microscopic examination.
Measured: Upto 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pityriasis VersicolorStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajira Amin, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922344
- Sponsor's protocol ID
- 84/DME/KMC
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient's confidentiality may be breached.
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor
- ClinicalTrials.gov ID
- NCT06922344
- Acronym / sponsor ID
- 84/DME/KMC
- Conditions
- Pityriasis Versicolor
- Keywords
- Pityriasis Versicolor, Fluconazole, Itraconazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Apr 2025 (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.
This study compares the efficacy of two drugs, namely flucanazole and itraconazole for the treatment of a common fungal infection of skin.
Detailed description
Pityriasis versicolor is a common fungal infection of the superficial skin layers. Avalible treatment options include topical and systemic drugs. fluconazole and itraconazole are commonly used systemic agents. The aim of this study is to compare the efficacy of the two systemic drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A, Fluconazole group | Experimental | Drug: FluconazoleGroup A consists of patients in whom oral fluconazole is given in dose of 300mg once weekly for 2 weeks. |
| Group B, Itraconazole group | Experimental | Drug: ItraconazoleGroup B consists of patients in whom oral Itraconazole is given in dose of 100mg Twice for 5 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All cases of Pityriasis versicolor
Key exclusion criteria (3 listed)
- Patients with history of chronic renal or liver disease, malignancy , or undergoing any kind of chemotherapy or radiotherapy or having cardiac conduction abnormalities.
- Patients who received any anti-fungal therapy in the last one month.
- Pregnant or lactating women.
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 |
|---|---|---|
| FluconazoleOral fluconazole prescribed to group A | Drug | Group A, Fluconazole group |
| ItraconazoleOral itraconazole prescribed to Group B | Drug | Group B, Itraconazole group |
Primary outcome
Efficacy of Treatment
Time frame: Upto 8 weeks
Efficacy of treatment is defined by absence of scaling by naked eye examination ,absence of yellow or golden scale reflection on woods lamp examination and absence of fungal hyphae on microscopic examination.
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 10 Apr 2025.
- Individual participant dataSharing planned: No. Patient's confidentiality may be breached.
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Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor.
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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 4 study testing Fluconazole and Itraconazole in people with Pityriasis Versicolor, run by Khyber Teaching Hospital 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 1 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: looking for participants now, as of the sponsor's last update on 10 Apr 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Treatment (time frame: Upto 8 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 10 Apr 2025.