Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor

April 9, 2025 updated by: Hajira Amin, Khyber Teaching Hospital
This study compares the efficacy of two drugs, namely flucanazole and itraconazole for the treatment of a common fungal infection of skin.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • KPK
      • Peshawar, KPK, Pakistan, 25000
        • Recruiting
        • Khyber Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All cases of Pityriasis versicolor

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A, Fluconazole group
Group A consists of patients in whom oral fluconazole is given in dose of 300mg once weekly for 2 weeks.
Drug: Fluconazole
Oral fluconazole prescribed to group A
Experimental: Group B, Itraconazole group
Group B consists of patients in whom oral Itraconazole is given in dose of 100mg Twice for 5 days.
Drug: Itraconazole
Oral itraconazole prescribed to Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Upto 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khyber Teaching Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 10, 2025

Study Record Updates

Last Update Posted (Actual)

April 10, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84/DME/KMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient's confidentiality may be breached.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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