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

Combined Military Hospital Abbottabad

Status and phase: Completed; Phase 1

Conditions: Tinea Versicolor

Treatments: Drug: Fluconazole; Drug: Itraconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT05862714

CMHAbbottabad1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 164 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Group A Fluconazole

Active Comparator group

Description:

Oral fluconazole (400 mg stat) given to patients.

Treatment:

Drug: Itraconazole

Drug: Fluconazole

Group B Itraconazole

Active Comparator group

Description:

Oral Itraconazole (1000 mg stat) given to patients.

Treatment:

Drug: Itraconazole

Drug: Fluconazole