Inclusion criteria: chronic and recurrent dermatophyte infections.
Exclusion criteria: age less than 15 and greater than 90 years, hyperlipidemia, abnormal renal and liver function tests, tinea capitis and unguum, pregnant and breastfeeding women.
Intervention groups
In Group A the patients were treated with oral voriconazole 200mg twice daily
In group B the patients were treated with oral itraconazole 100mg twice daily
Treatment given for four weeks or less in patients in which complete response is achieved.
Main outcome variables
Treatment of dermatophyte infections based on clinical response and microscopic findings using KOH solution
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210823052264N3
Registration date:2023-05-19, 1402/02/29
Registration timing:registered_while_recruiting
Last update:2023-05-19, 1402/02/29
Update count:0
Registration date
2023-05-19, 1402/02/29
Registrant information
Name
Najia Ahmed
Name of organization / entity
PNS shifa
Country
Pakistan
Phone
+92 81 2864092
Email address
najiaomer@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-25, 1402/02/05
Expected recruitment end date
2023-10-25, 1402/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral voriconazole versus oral itraconazole in the treatment of dermatophyte infections
Public title
Efficacy of oral voriconazole versus itraconazole in the treatment of dermatophyte infections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic and recurrent dermatophyte infections (chronic refers to infections present for over 6 months, recurrent refers to patients with an infection in which symptoms reappear in 6 weeks after complete cure or stopping of treatment).
Exclusion criteria:
Patients with age less than 15 and greater than 90 years,
Hyperlipidemia,
Abnormal liver and renal function tests,
Pregnant and breast feeding females.
Age
From 15 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization done by lottery method, in which small chits of paper are kept in a jar and the patients will be asked to pick one deciding their treatment regimen.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participant, the investigator and outcome assesor were all blinded except for one physician who was supposed to recruit the patients in the group. As explained above the participants will be asked to pick up a chit of paper from a jar that will decide in which group they will fall into. The participants will not open the chit themselves, but will hand it over to the non blinded accessor, who will give them the medicine without any label showing the brand or generic name.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ehical review committee, PNS Shifa
Street address
PNS Shifa Hospital, DHA Phase 2, Karachi
City
Karachi
Postal code
75500
Approval date
2023-04-27, 1402/02/07
Ethics committee reference number
ERC/2023/DERMA/14
Health conditions studied
1
Description of health condition studied
Dermatophyte infection
ICD-10 code
B35
ICD-10 code description
Dermatophytosis
Primary outcomes
1
Description
Clinical response based on clearence of lesion and absence of fungal hyphae on KOH microscopy
Timepoint
Patients were evaluated clinically on 7th and 14th day of treatment and 4 weeks after completion of treatment.
Method of measurement
Clinical evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group "A" patietns were treated with Tab Voriconazole 200mg twice a day for four weeks or less in patients in which clinical response is achieved
Category
Treatment - Drugs
2
Description
Intervention group: In group "B" patients were treated with Tab Itraconazole 100md twice daily for four weeks or less in which clinical response is achieved
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
PNS Shifa Hospital
Full name of responsible person
Dr Maira Ali
Street address
Main Korangi Rd, Near Kala Pul, DHA Phase 2, Clifton, Karachi
City
Karachi
Postal code
74900
Phone
+92 332 3676671
Fax
+92 21 48506592
Email
mairasmuian2012@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PNS SHIFA
Full name of responsible person
Dr Maira Ali
Street address
Main Korangi Rd, nea Kala Pul, Clifton, Karachi
City
Karachi
Postal code
74900
Phone
+92 21 48506592
Fax
+92 21 48506592
Email
mairasmuian2012@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
PNS SHIFA
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
PNS Shifa
Full name of responsible person
Dr Maira Ali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dr Maira Ali, 5th Floor, OPD Tower, PNS Shifa Hospital
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 21 48506592
Fax
Email
mairasmuian2012@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PNS SHIFA
Full name of responsible person
Dr Maira Ali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dr Maira Ali, 5th Floor, OPD Tower, PNS Shifa Hospital
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 21 48506592
Email
mairasmuian2012@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
PNS SHIFA
Full name of responsible person
Dr Maira Ali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dr Maira Ali, 5th Floor, OPD
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 21 48506592
Email
mairasmuian2012@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Primary outcome
When the data will become available and for how long
1 month after the trial and for lifetime
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Many
From where data/document is obtainable
mairasmuian2012gmail.com
What processes are involved for a request to access data/document