Comparative Efficacy of Topical 1% Clotrimazole vs Oral Itraconazole in the Treatment of Pityriasis Versicolor

January 5, 2026 updated by: Zaeema Aman, Combined Military Hospital Abbottabad
Comparative efficacy of topical 1% clotrimazole vs oral itraconazole in the treatment of pityriasis versicolor -Randomized control trial

Study Overview

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age (15-50 years)
  • Both genders
  • Sufferers of Pityriasis versicolor ( Determined by scale , erythema and pruritus)

Exclusion Criteria:

  • Pt with history of antifungals in last one month
  • Pt on immunosuppressants or steroid therapy
  • Pregnant and lactating women
  • Pt with chronic medical conditions ( Diabetes and hypertension)

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: 1% Clotrimazole
topical 1 % clotrimazole twice daily for 2 weeks
Topical 1% clotrimazole twice daily for 2 weeks
Experimental: Itraconazole
Oral itraconazole 200mg daily 5 days
Oral itraconazole 200mg daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentile efficacy of topical versus oral antifungal in the treatment of pityriasis versicolor
Time Frame: 3 months
Data analysis will be performed using SPSS version 20. The quantitative variable (age, BMI and duration of PV) will be presented as mean ± standard deviation (SD) or median interquartile range (IQR) after checking normality of data by using Shapiro-Wilk test. Frequency and percentages will be used for categorical variables (gender, severity of PV, area of residence, level of education and efficacy). Efficacy will be compared between groups using Chi-square or Fisher exact test. Efficacy will be stratified by age, gender, BMI, duration of PV and severity of PV to deal with effect modifiers. Post-stratification chi-square test or Fischer exact test will be used as test of significance. A p-value of ≤ 0.05 will be considered statistically significant.
3 months

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Estimated)

February 2, 2026

Primary Completion (Estimated)

May 2, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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