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

NCT07331792 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: CMH-Atd-ETH-200-Derm-25
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparative efficacy of topical 1% clotrimazole vs oral itraconazole in the treatment of pityriasis versicolor -Randomized control trial

Conditions

Pityriasis Versicolor

Outcome Measures

Primary Outcomes (1)

• Percentile efficacy of topical versus oral antifungal in the treatment of pityriasis versicolor

  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

Study Arms (2)

1% Clotrimazole

EXPERIMENTAL

topical 1 % clotrimazole twice daily for 2 weeks

Drug: Topical 1 % clotrimazole twice daily 2 weeks

Itraconazole

EXPERIMENTAL

Oral itraconazole 200mg daily 5 days

Drug: Oral itraconazole 200mg daily for 5 days

Interventions

Topical 1 % clotrimazole twice daily 2 weeks DRUG

Topical 1% clotrimazole twice daily for 2 weeks

1% Clotrimazole

Oral itraconazole 200mg daily for 5 days DRUG

Oral itraconazole 200mg daily for 5 days

Itraconazole

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Related Publications (5)

• 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

  BACKGROUND

• 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.

  PMID: 39079943 BACKGROUND

• 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.

  PMID: 35751534 BACKGROUND

• 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.

  PMID: 36452877 BACKGROUND

• 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.

  PMID: 37895478 BACKGROUND

MeSH Terms

Conditions

Tinea Versicolor

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Central Study Contacts

Zaeema Aman, MBBS

CONTACT

+923200400726; zaeema.aman@gmail.com

Ali Amar, MBBS, FCPS

CONTACT

+923215625426; docaliamar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resisent Dermatology

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 12, 2026
• Study Start: February 2, 2026
• Primary Completion: May 2, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share