- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07331792
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
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
- Name: Zaeema Aman, MBBS
- Phone Number: +923200400726
- Email: zaeema.aman@gmail.com
Study Contact Backup
- Name: Ali Amar, MBBS, FCPS
- Phone Number: +923215625426
- Email: docaliamar@gmail.com
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.
General Publications
- Bamford JTM, Flores-GenuinoRNS, Ray S, Bigby M, Morales-Sánchez MA, Arkoncel M, et al. Interventions for the treatment of pityriasis versicolor. Cochrane Database Syst Rev. 2018;2018(6):CD011208. https://doi.org/10.1002/14651858.CD011208.pub2
- Hill RC, Faria W, Gold JAW, Lipner SR. Factors associated with pityriasis versicolor in a large national database. Mycoses. 2024 Aug;67(8):e13775. doi: 10.1111/myc.13775.
- Kurniadi I, Hendra Wijaya W, Timotius KH. Malassezia virulence factors and their role in dermatological disorders. Acta Dermatovenerol Alp Pannonica Adriat. 2022 Jun;31(2):65-70.
- Leung AK, Barankin B, Lam JM, Leong KF, Hon KL. Tinea versicolor: an updated review. Drugs Context. 2022 Nov 14;11:2022-9-2. doi: 10.7573/dic.2022-9-2. eCollection 2022.
- Labedz N, Navarrete-Dechent C, Kubisiak-Rzepczyk H, Bowszyc-Dmochowska M, Pogorzelska-Antkowiak A, Pietkiewicz P. Pityriasis Versicolor-A Narrative Review on the Diagnosis and Management. Life (Basel). 2023 Oct 22;13(10):2097. doi: 10.3390/life13102097.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMH-Atd-ETH-200-Derm-25
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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