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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Versicolor
• Intervention / Treatment: Drug: Fluconazole; Drug: Itraconazole

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Abbottābād, Khyber Pakhtunkhwa, Pakistan, 22010
      • CMH Abbottabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Combined Military Hospital Abbottabad

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: March 30, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin Diseases, Papulosquamous; Mycoses; Dermatomycoses; Tinea Versicolor; Pityriasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Itraconazole; Fluconazole
• Other Study ID Numbers: CMHAbbottabad1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No