Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor
Primary Purpose
Tinea Versicolor
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Fluconazole
Itraconazole
Sponsored by
About this trial
This is an interventional treatment trial for Tinea Versicolor
Eligibility Criteria
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
Sites / Locations
- CMH Abbottabad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A Fluconazole
Group B Itraconazole
Arm Description
Oral fluconazole (400 mg stat) given to patients.
Oral Itraconazole (1000 mg stat) given to patients.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05862714
First Posted
March 30, 2023
Last Updated
May 8, 2023
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05862714
Brief Title
Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor
Official Title
Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Versicolor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A Fluconazole
Arm Type
Active Comparator
Arm Description
Oral fluconazole (400 mg stat) given to patients.
Arm Title
Group B Itraconazole
Arm Type
Active Comparator
Arm Description
Oral Itraconazole (1000 mg stat) given to patients.
Intervention Type
Drug
Intervention Name(s)
Fluconazole
Other Intervention Name(s)
Fluderm
Intervention Description
400 mg stat. Follow up at 4 weeks
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Other Intervention Name(s)
Icon
Intervention Description
1000 mg stat. Follow up at 4 weeks
Primary Outcome Measure Information:
Title
Clinical Improvement Resolution of symptoms
Description
Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks
Time Frame
4 weeks
Title
Efficacy of treatment through KOH mount
Description
Efficacy of treatment was assessed by mycological test by making KOH mount at start of treatment and than at follow up at 4 weeks
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
CMH Abbottabad
City
Abbottābād
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22010
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor
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