Comparison of Efficacy of Single Oral Dose Fluconazole and Itraconazole in Patients With Pityriasis Versicolor
1 other identifier
interventional
164
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFirst Submitted
Initial submission to the registry
March 30, 2023
CompletedFirst Posted
Study publicly available on registry
May 17, 2023
CompletedMay 17, 2023
May 1, 2023
7 months
March 30, 2023
May 8, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Group A Fluconazole
ACTIVE COMPARATOROral fluconazole (400 mg stat) given to patients.
Group B Itraconazole
ACTIVE COMPARATOROral Itraconazole (1000 mg stat) given to patients.
Interventions
400 mg stat. Follow up at 4 weeks
1000 mg stat. Follow up at 4 weeks
Eligibility Criteria
You may qualify if:
- All the patients above 18 years of age
- Diagnosed with pityriasis versicolor
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CMH Abbottabad
Abbottābād, Khyber Pakhtunkhwa, 22010, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 30, 2023
First Posted
May 17, 2023
Study Start
March 1, 2022
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
May 17, 2023
Record last verified: 2023-05