Investigation the effect of terbinafine and itraconazole on the treatment of tinea incognita in patients referring to the Haj Daee clinic of Kermanshah
Design
This study is a clinical trial on 50 eligible patients with tinea incognita which will be randomly assigned into two intervention groups.
Settings and conduct
This study will be conducted on 50 patients with primary diagnosis of tinea incognita coming to Haj Daee clinic of Kermanshah city. Participants will be will be assigned non-randomly into intervention groups. The study is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: More than 15 years; Local or systemic corticosteroid use for fungal infection
Exclusion criteria:Immune system weakness; History of allergy to antifungal drugs; Breastfeeding and pregnancy
Intervention groups
The first intervention group will receive 250mg Terbinafine tablets for 4 weeks daily .
The second intervention group will receive 100 mg of itraconazole capsule for 4 weeks daily.
Main outcome variables
Itching, redness of the skin, scaling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090515001906N12
Registration date:2018-04-16, 1397/01/27
Registration timing:registered_while_recruiting
Last update:2018-04-16, 1397/01/27
Update count:0
Registration date
2018-04-16, 1397/01/27
Registrant information
Name
Ali Ebrahimi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1823 3862
Email address
aebrahimi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-25, 1397/01/05
Expected recruitment end date
2018-05-26, 1397/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of terbinafine and itraconazole on the treatment of tinea incognita
Public title
The effect of terbinafine and itraconazole on the treatment of topical skin fungal infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
More than 15 years
Local or systemic corticosteroid use for fungal infection
Exclusion criteria:
Immune system weakness
History of allergy to antifungal drugs
Taking anticoagulant drugs such as heparin and warfarin
Pregnancy
Lactation and culture-negative
Age
From 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2016-12-14, 1395/09/24
Ethics committee reference number
kums.rec.1395.537
Health conditions studied
1
Description of health condition studied
Tinea incognito
ICD-10 code
B35.9
ICD-10 code description
Dermatophytosis, unspecified
Primary outcomes
1
Description
Itching
Timepoint
The beginning of the study; The second week; The fourth; The eighth and twelfth
Method of measurement
By asking the patient
2
Description
Skin redness
Timepoint
The beginning of the study; The second week; The fourth; The eighth and twelfth
Method of measurement
Physician observation
3
Description
Flaking
Timepoint
The beginning of the study; The second week; The fourth; The eighth and twelfth
Method of measurement
Physician observation
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 250mg Terbinafine tablets for 4 weeks daily
Category
Treatment - Drugs
2
Description
. The second intervention group will receive 100 mg of isotretinoic acid capsule for 4 weeks daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Haj Doei Clinic
Full name of responsible person
Sepideh Hamzehei
Street address
Mostafa Emami Boulevard, Golestan Quarter
City
Kermanshah
Province
Kermanshah
Postal code
6714643451
Phone
+98 83 3835 7070
Email
sepidehhamzehei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Kermanshah University of Medical Sciences
Full name of responsible person
Sepideh Hamzehei
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Fax
Email
sepidehhamzehei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Ali Ebrahimi
Position
Member of Scientific Board of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
Ebrahimider@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sepideh Hamzehei
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
sepidehhamzehei@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
2 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail