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

Sponsor
Combined Military Hospital Abbottabad (Other)
Overall Status
Completed
CT.gov ID
NCT05862714
Collaborator
(none)
164
Enrollment
1
Location
2
Arms
7
Actual Duration (Months)
23.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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
Actual Enrollment :
164 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Sep 30, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Improvement Resolution of symptoms [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

    2. Efficacy of treatment through KOH mount [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CMH Abbottabad Abbottābād Khyber Pakhtunkhwa Pakistan 22010

    Sponsors and Collaborators

    • Combined Military Hospital Abbottabad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Aleena Nasir, Principal Investigator, Combined Military Hospital Abbottabad
    ClinicalTrials.gov Identifier:
    NCT05862714
    Other Study ID Numbers:
    • CMHAbbottabad1
    First Posted:
    May 17, 2023
    Last Update Posted:
    May 17, 2023
    Last Verified:
    May 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tinea Versicolor
    Pityriasis
    Itraconazole
    Fluconazole

    Study Results

    No Results Posted as of May 17, 2023