Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor

Study Overview
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Brief Summary
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Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic fungal infection of the skin caused by species of lipophilic yeast known as Malassezia species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic bis-triazole compound. Only a few studies are available to find a direct comparison of the efficacy of single dose of oral fluconazole (400 mg) and oral itraconazole (1000 mg) in the treatment of PV. The objective of the study was to compare the efficacy of single dose fluconazole (400 mg stat) to single dose itraconazole (1000 mg stat) in the treatment of pityriasis versicolor in the local population of Pakistan.

Detailed Description
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Pityriasis versicolor (PV) also called tinea versicolor is a common superficial chronic fungal infection of the skin caused by species of lipophilic yeast known as Malassezia species. Itraconazole is an oral synthetic triazole while fluconazole is an oral synthetic bis-triazole compound. These both acts by inhibiting the cytochrome-P450 dependent 14-alpha-demethylation step in the formation of ergosterol thereby impairing the functions of certain membrane bound enzyme systems, and ultimately inhibiting the growth of fungi. Both the drugs have been studied in different dose regimen, however, there are variable results in studies on this subject. There is still no standard drug and its dosage that can ensure complete cure. Fluconazole (300mg) in 2 doses with an interval of one week has been used effectively, however, fluconazole (400 mg) as a single dose has also been used, and found to cure the PV. Itraconazole 200 mg/day can be given in a dose of for 7 days however, higher concentrations of itraconazole in the stratum corneum are achieved that persist for 3-4 weeks so the drug is presumed to be effective even in a single dose. Therefore, only a few studies are available to find a direct comparison of the efficacy of single dose of oral fluconazole (400 mg) and oral itraconazole (1000 mg) in the treatment of PV. The objective of the study was to compare the efficacy of single dose fluconazole (400 mg stat) to single dose itraconazole (1000 mg stat) in the treatment of pityriasis versicolor in the local population of Pakistan.

Official Title
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Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor

Conditions
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Tinea Versicolor

Intervention / Treatment
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* Drug: Fluconazole
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients above 18 years of age Diagnosed with pityriasis versicolor Exclusion Criteria: Those patients who had received any antifungal treatment during last 1 month pregnancy lactation history of renal disease hepatic disease or malignancy history of hepatic disease history of malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A Fluconazole<br>Oral fluconazole (400 mg stat) given to patients. | Drug: Fluconazole<br>* 400 mg stat. Follow up at 4 weeks<br>* Other names: Fluderm;Drug: Itraconazole<br>* 1000 mg stat. Follow up at 4 weeks<br>* Other names: Icon;|
| Active Comparator: Group B Itraconazole<br>Oral Itraconazole (1000 mg stat) given to patients. | Drug: Fluconazole<br>* 400 mg stat. Follow up at 4 weeks<br>* Other names: Fluderm;Drug: Itraconazole<br>* 1000 mg stat. Follow up at 4 weeks<br>* Other names: Icon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement Resolution of symptoms | Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks | 4 weeks | 
| Efficacy of treatment through KOH mount | Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks | 4 weeks |