The main aim of this study: efficacy of topical terbinafine and ketoconazole in pityriasis versicolor ( rct –single blind)
Inclusion criteria are: KOH positive ; involvement of less than 10% of the body surface by the lesions. Exclusion criteria are: Extensive involvement of the skin ; topical or systemic antifungal therapy; and use of steroid or antibiotic within the last month before starting the study
The samples wile be examined microscopically for the presence of mycelium by a pathologist if the smears are positive for mycelium. Sample size in study 100 patients they will be allocated to 2 groups randomly.
Intervention group will use t terbinafin hydrochloride 1% cream.the creams are used topically twice a day for 2 weeks.
. determined clinically based on observation of signs and symptoms. Itching, scaling and redness are the clinical
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107184808N4
Registration date:2011-11-13, 1390/08/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-11-13, 1390/08/22
Registrant information
Name
Mozhdeh Zarei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 1613 1278
Email address
mozh.zarei@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2010-04-19, 1389/01/30
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of topical terbinafine and ketoconazole in pityriasis versicolor
Public title
Versicolor Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are:Age above 14 years; KOH positive ; involvement of less than 10% of the body surface by the lesions.
Exclusion criteria are:Extensive involvement of the skin ; topical or systemic antifungal therapy; and use of steroid or antibiotic within the last month before starting the study;pregnancy or likelihood of pregnancy; lactation and the patients who are not cooperative
Age
From 14 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
KURDISTAN University of Medical Sciences
Street address
KURDISTAN University of Medical Sciences
City
SANANDAJ
Postal code
6617711446
Approval date
2011-03-19, 1389/12/28
Ethics committee reference number
14/1203 28/12/1389
Health conditions studied
1
Description of health condition studied
versicolor
ICD-10 code
B36.0
ICD-10 code description
Pityriasis versicolor
Primary outcomes
1
Description
PTRIASIS versicolor
Timepoint
After completion of the treatment course the patients will be requested to refer for follow up after 1 weeks, one month and two months of treatment or in case of recurrence of the lesions.
Method of measurement
Skin smears are taken by a scalpel or a tape and will be examined by a pathologist for the presence of mycelium. The patients with positive smears will enter into the study.
Secondary outcomes
1
Description
LOCAL complications
Timepoint
after 2 weeks, one month and two months of treatment
Method of measurement
by a physician or patient self-report
Intervention groups
1
Description
CONTROL: ketoconazol 2% cream .the creams are used topically twice a day for 2 weeks.
Category
Treatment - Drugs
2
Description
INTERVENTIONAL:terbinafin hydrochloride 1% cream.the creams are used topically twice a day for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor's office . BESATHOSPITAL
Full name of responsible person
DR.FAROKH RAD
Street address
KURDISTAN University of Medical Sciences
City
SANANDAJ
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
KURDISTAN University of Medical Sciences
Full name of responsible person
MOZHDEH ZAREI
Street address
KURDISTAN University of Medical Sciences
City
SANANDAJ
Grant name
Grant code / Reference number
25000000 R
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
KURDISTAN 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
MEDICAL UNIVERSITY OF KURDISTAN
Full name of responsible person
DR FAROKH RAD
Position
dermatologist
Other areas of specialty/work
Street address
KURDISTAN University of Medical Sciences
City
SANANDAJ
Postal code
6617711446
Phone
+98 87 1613 1278
Fax
+98 87 1666 5354
Email
MOZH.ZAREI@MUK.AC.IR
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
KURDISTAN University of Medical Sciences
Full name of responsible person
DR Farokh Rad
Position
dermatologist
Other areas of specialty/work
Street address
KURDISTAN province, Sanandaj, PASDARAN avenue, KURDISTAN University of Medical Sciences
City
SANANDAJ
Postal code
6617711446
Phone
+98 87 1613 1278
Fax
+98 87 1666 5354
Email
mozh.zarei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Medical University OF KURDISTAN
Full name of responsible person
DR Farokh Rad
Position
dermatologist
Other areas of specialty/work
Street address
KURDISTAN University of Medical Sciences
City
Sanandaj
Postal code
6617711446
Phone
+98 87 1613 1278
Fax
+98 87 1666 5354
Email
MZH.ZAREI@MUK.AC.IR
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)