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

Tinea Versicolor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05862714
• Other study ID #: CMHAbbottabad1
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: May 2023
• Source: Combined Military Hospital Abbottabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Tinea Versicolor

Intervention

Drug:
• Fluconazole
400 mg stat. Follow up at 4 weeks
• Itraconazole
1000 mg stat. Follow up at 4 weeks

Locations

Country	Name	City	State
Pakistan	CMH Abbottabad	Abbottabad	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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