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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2022-09-30

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.

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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.

Conditions

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Tinea Versicolor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A Fluconazole

Oral fluconazole (400 mg stat) given to patients.

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

400 mg stat. Follow up at 4 weeks

Itraconazole

Intervention Type DRUG

1000 mg stat. Follow up at 4 weeks

Group B Itraconazole

Oral Itraconazole (1000 mg stat) given to patients.

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

400 mg stat. Follow up at 4 weeks

Itraconazole

Intervention Type DRUG

1000 mg stat. Follow up at 4 weeks

Interventions

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Fluconazole

400 mg stat. Follow up at 4 weeks

Intervention Type DRUG

Itraconazole

1000 mg stat. Follow up at 4 weeks

Intervention Type DRUG

Other Intervention Names

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes