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Clinical Trials/NCT05862714
NCT05862714CompletedPhase 1

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

Combined Military Hospital Abbottabad1 site in 1 country164 target enrollmentStarted: March 1, 2022Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
164
Locations
1
Primary Endpoint
Clinical Improvement Resolution of symptoms

Study Overview

Brief 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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Group A Fluconazole

Active Comparator

Oral fluconazole (400 mg stat) given to patients.

Intervention: Fluconazole (Drug)

Group A Fluconazole

Active Comparator

Oral fluconazole (400 mg stat) given to patients.

Intervention: Itraconazole (Drug)

Group B Itraconazole

Active Comparator

Oral Itraconazole (1000 mg stat) given to patients.

Intervention: Fluconazole (Drug)

Group B Itraconazole

Active Comparator

Oral Itraconazole (1000 mg stat) given to patients.

Intervention: Itraconazole (Drug)

Outcomes

Primary Outcomes

Clinical Improvement Resolution of symptoms

Time Frame: 4 weeks

Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks

Efficacy of treatment through KOH mount

Time Frame: 4 weeks

Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Combined Military Hospital Abbottabad
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Aleena Nasir

Principal Investigator

Combined Military Hospital Abbottabad

Study Sites (1)

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