NCT06922344

Brief Summary

This study compares the efficacy of two drugs, namely flucanazole and itraconazole for the treatment of a common fungal infection of skin.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 10, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

April 3, 2025

Last Update Submit

April 9, 2025

Conditions

Keywords

Pityriasis VersicolorFluconazoleItraconazole

Outcome Measures

Primary Outcomes (1)

  • Efficacy of Treatment

    Efficacy of treatment is defined by absence of scaling by naked eye examination ,absence of yellow or golden scale reflection on woods lamp examination and absence of fungal hyphae on microscopic examination.

    Upto 8 weeks

Study Arms (2)

Group A, Fluconazole group

EXPERIMENTAL

Group A consists of patients in whom oral fluconazole is given in dose of 300mg once weekly for 2 weeks.

Drug: Fluconazole

Group B, Itraconazole group

EXPERIMENTAL

Group B consists of patients in whom oral Itraconazole is given in dose of 100mg Twice for 5 days.

Drug: Itraconazole

Interventions

Oral fluconazole prescribed to group A

Group A, Fluconazole group

Oral itraconazole prescribed to Group B

Group B, Itraconazole group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All cases of Pityriasis versicolor

You may not qualify if:

  • Patients with history of chronic renal or liver disease, malignancy , or undergoing any kind of chemotherapy or radiotherapy or having cardiac conduction abnormalities.
  • Patients who received any anti-fungal therapy in the last one month.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital

Peshawar, KPK, 25000, Pakistan

RECRUITING

MeSH Terms

Conditions

Tinea Versicolor

Interventions

FluconazoleItraconazole

Condition Hierarchy (Ancestors)

DermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

April 3, 2025

First Posted

April 10, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Patient's confidentiality may be breached.

Locations