The objective of this randomized, trial is comparing the treatment effects and complications of oral terbinafin and grisofulvin in 50 patients suffering from tinea capitis. In this study, patients presented with tinea capitisl and documented by KOH or culture were included in study. Patients with Pregnancy:infantile: breastfeeding: sensitivity to terbinafin and grisofulvin and previous treatment with antifungal drugs
were excluded from the study. After taking the written informed consent, demographic and clinical data were recorded in a questionnaire. In one group of patients, treatment with oral grisofulvin 10 mg/kg and in another group,treatment with oral terbinafin 5 mg/kg was prescribed for 1 month. Patients were followed up for outcome and probable complications at the end of the second week and first and second month. Finally,the treatment outcomes including cure rate and complications such as persistent infection and recurrence were compared by appropriate statistical test in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704056403N8
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Hossein Kavoussi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1837 5424
Email address
hkawosi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of medical sciences
Expected recruitment start date
2017-09-10, 1396/06/19
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral terbinafin and grisofulvin in the treatment of tinea capitis
Public title
Treatment of tinea capitis by oral terbinafin and grisofulvin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Tinea documented by laboratory assessment
Exclusion criteria: Pregnancy: infancy, breastfeeding: sensitivity to terbinafin and grisofulvin: previous treatment with antifungal drugs
Age
From 2 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
NO
Secondary trial Id
NO
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Scienses
Street address
Shahid Beheshty Blvd
City
Kermanshah
Postal code
Approval date
2016-11-23, 1395/09/03
Ethics committee reference number
kUMS.REC.1395.512
Health conditions studied
1
Description of health condition studied
Tinea capitis
ICD-10 code
L00-L99
ICD-10 code description
B35-B49
Primary outcomes
1
Description
Treatment of tinea capitis
Timepoint
The end of 2th week, 1th, 2th and 3th months
Method of measurement
clinical observation and laboratory assesment
Secondary outcomes
1
Description
Recurrence
Timepoint
The end 1 week, 1th, 2th and 3th months
Method of measurement
Clinical observation and labratory assesmsnt
2
Description
Permanent hair loss
Timepoint
The end 1 week, 1th, 2th and 3th months
Method of measurement
Clinical observation
Intervention groups
1
Description
In one group treatment with oral grisofulvin
In other group treatment with oral terbinafin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajdaie clinic
Full name of responsible person
Hossein Kavoussi
Street address
Golestan blvd
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr Behrouz Hamzeh
Street address
Department of Vice Chancellor for reaserch and technology,Shahid Beheshty Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
ِDr Hossein Kavoussi
Position
Associate Professour
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
Phone
+98 83 3825 6643
Fax
Email
hkawosi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Ali Ebrahimi
Position
Associate Professour
Other areas of specialty/work
Street address
Hajdaie clinic, Golestan Blvd
City
Kermanshah
Postal code
Phone
+98 83 3825 6643
Fax
Email
aebrahimh@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Reza Kavoussi
Position
Medical Student
Other areas of specialty/work
Street address
Sayyad shirazy street, medical school
City
Kermanshah
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)