Efficacy of oral itraconazole with sertaconazole cream versus oral itraconazole with clotrimazole cream in dermatophytosis - a randomized controlled trial in a tertiary care hospital in Pakistan
In this study, we aim to measure the efficacy of oral itraconazole with sertaconazole cream versus oral itraconazole with clotrimazole cream in dermatophytosis
Design
A randomized controlled trial with two parallel intervention groups; double-blind; phase 3; on 118 patients.
Inclusion criteria: Patients of both, male and female genders, in age group 12-75 years with clinical manifestations of cutaneous dermatophyte infections (tinea corporis/tinea cruris/tinea faciei) and confirmation done with skin scraping positive for potassium hydroxide (KOH) mount.
Exclusion criteria: Patients with age less than 12 years and greater than 75 years.
Hyperlipidemia
Abnormal liver function tests
Pregnant and breast feeding females.
solitary lesion which is less than 3 cm in diameter
hypersensitivity to antifungals
if patients are on any systemic medications known to have interactions with itraconazole
superadded bacterial infections
patients on immunosuppressive drugs
patients who are known case of liver or renal disease
Tinea capitis and onychomycosis
Intervention groups
In Group A the patients were treated with oral itraconazole 100mg twice daily with topical sertaconazole cream. In Group B, the patients were treated with oral itraconazole 100mg twice daily with topical clotrimazole cream. 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:IRCT20230531058353N1
Registration date:2023-08-07, 1402/05/16
Registration timing:registered_while_recruiting
Last update:2023-08-07, 1402/05/16
Update count:0
Registration date
2023-08-07, 1402/05/16
Registrant information
Name
Absha Abbasi
Name of organization / entity
PNS Shifa Hospital
Country
Pakistan
Phone
+92 21 48506482
Email address
abshaabbasi5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-26, 1402/04/05
Expected recruitment end date
2023-12-26, 1402/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of oral itraconazole with sertaconazole cream versus oral itraconazole with clotrimazole cream in dermatophytosis - a randomized controlled trial in a tertiary care hospital in Pakistan
Public title
Efficacy of oral itraconazole with sertaconazole cream versus oral itraconazole with clotrimazole cream in dermatophytosis - a randomized controlled trial in a tertiary care hospital in Pakistan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of both, male and female genders, in age group 12-75 years with clinical manifestations of cutaneous dermatophyte infections (tinea corporis/tinea cruris/tinea faciei) and confirmation done with skin scraping positive for potassium hydroxide (KOH) mount.
Exclusion criteria:
Patients with age less than 12 years and greater than 75 years.
Hyperlipidemia
Abnormal liver function tests
Pregnant and breast feeding females.
solitary lesion which is less than 3 cm in diameter
hypersensitivity to antifungals
if patients are on any systemic medications known to have interactions with itraconazole
superadded bacterial infections
patients on immunosuppressive drugs
patients who are known case of liver or renal disease
Tinea capitis and onychomycosis
Age
From 12 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
118
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. Half of the chits will be Group A and half of the chits will be Group B. Chits will be folded uniformly to conceal their identity.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participant, the investigator and outcome assessor 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 be decide in which group they will fall into. Half of the chits will be Group A and half of the chits will be Group B. The chits will be folded uniformly to conceal identity. 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
Ethical review committee, PNS Shifa
Street address
PNS Shifa Hospital, DHA Phase 2, Karachi, Pakistan
City
Karachi
Postal code
75500
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
ERC/2023/DERM/30
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 evaluation and absence of fungal hyphae on KOH microscopy.
Timepoint
Patients were evaluated clinically on 2 weeks of treatment then 4 weeks of treatment (end point) and then further followed up after 4 weeks.
Method of measurement
Clinical evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In group "A", patients were treated with Tab Itraconazole 100mg twice a day and sertaconazole cream applied topically twice a day for 4 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 100 mg twice a day and clotrimazole cream applied twice a day for 4 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 Absha Abbasi
Street address
Main Korangi Rd, near Kala Pul, DHA Phase 2, Clifton, Karachi
City
Karachi
Postal code
74900
Phone
+92 334 2650223
Email
abshaabbasi5@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PNS Shifa
Full name of responsible person
Dr Absha Abbasi
Street address
Main Korangi Rd, near Kala Pul, Clifton, Karachi, SIndh, Pakistan
City
Karachi
Postal code
74900
Phone
+92 21 48506592
Email
abshaabbasi5@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 Absha Abbasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dr Absha Abbasi, 5th floor, OPD Tower, PNS Shifa Hospital
City
Karachi
Province
SIndh
Postal code
74900
Phone
+92 21 48506592
Email
abshaabbasi5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
PNS Shifa
Full name of responsible person
Dr Absha Abbasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dr Absha Abbasi, 5th Floor, OPD Tower, PNS Shifa Hospital
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 21 48506592
Email
abshaabbasi5@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
PNS Shifa
Full name of responsible person
Dr Absha Abbasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dr Absha Abbasi, 5th Floor, OPD Tower, PNS Shifa Hospital
City
Karachi
Province
Sindh
Postal code
74900
Phone
+92 21 48506592
Email
abshaabbasi5@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
abshaabbasi5@gmail.com
What processes are involved for a request to access data/document