Because of side effect of oral treatment and drug resistance, we decided to compare the therapeutic efficacy of topical Terbinafine versus topical Ketoconazole for treatment of Tinea Versicolor. Material & methods: Sixty nine patients with a clinical diagnosis of Pityriasis versicolor confirmed by microscopic potassium hydroxide (KOH) examination entered the study. Patients randomly assigned to one of 2 treatment groups: 35 patients in Terbinafine group, treated by Terbinafine 1% once daily for 2 weeks and 34 patients in Ketoconazole group, treated with Ketoconazole 2% once daily for 2 weeks. Patients were followed up at monthly intervals for 3 months and recurrence and cure rates were calculated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903194128N1
Registration date:2010-09-09, 1389/06/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-09-09, 1389/06/18
Registrant information
Name
Majid Rostami
Name of organization / entity
Ardebil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1224 6687
Email address
m.rostami@arums.ir
Recruitment status
Recruitment complete
Funding source
Ardebil University of Medical Sciences
Expected recruitment start date
2007-03-21, 1386/01/01
Expected recruitment end date
2008-03-20, 1387/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the therapeutic efficacy of Terbinafine and Ketoconazole in treatment of Tinea Versicolor
Public title
Comparing the therapeutic efficacy of Terbinafine and Ketoconazole in treatment of Tinea Versicolor
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with Tinea Versicoler and positive smear. Exclusion criteria: pregnancy, sensitivity to Ketoconazole and Terbinafihne, receiving antifungoal drugs during 1 month ego, liver disease.
Age
From 16 years old to 37 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
69
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Ardabil
Street address
Basij squar
City
Ardabil
Postal code
5615778511
Approval date
2008-03-03, 1386/12/13
Ethics committee reference number
186
Health conditions studied
1
Description of health condition studied
Tinea Versicolor
ICD-10 code
L00-L08
ICD-10 code description
Infections of the skin and subcutaneous tissue
Primary outcomes
1
Description
cilinical improvment
Timepoint
1 month
Method of measurement
cilinical observation
Secondary outcomes
1
Description
drug compilications.
Timepoint
2 weak post treatment and monthly intervals for 3 months .
Method of measurement
cilinical observation
Intervention groups
1
Description
Ketoconazole group: Ketoconazole 2% once daily for 2 weeks
Category
Treatment - Drugs
2
Description
Terbinafine group: Terbinafine 1% once daily for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hospital
Full name of responsible person
Majid Rostami
Street address
Assistant prof., Ardabil university of medical sciences
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Ardabil
Full name of responsible person
Seiied Saeid Hashemein
Street address
Basij square
City
Ardabil
Grant name
عمومی
Grant code / Reference number
161
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Ardabil
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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Majid Rostami
Position
Assistant prof, Dermatologist
Other areas of specialty/work
Street address
Ardebil University of Medical Sciences
City
Ardabil
Postal code
5615778511
Phone
+98 45 1224 6687
Fax
+98 45 1224 6687
Email
m.rostami@arums
Web page address
www.arums.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil university of medical sciences
Full name of responsible person
Majid Rostami Mogaddam
Position
Assistant prof
Other areas of specialty/work
Street address
Ardabil university of medical sciences
City
Ardabil
Postal code
5615778511
Phone
+98 45 1224 6687
Fax
+98 45 1224 6687
Email
m.rostami@arums
Web page address
www.arums.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil university of medical sciences
Full name of responsible person
Majid Rostami Mogaddam
Position
Assistant prof
Other areas of specialty/work
Street address
Ardabil university of medical sciences
City
Ardabil
Postal code
5615778511
Phone
+98 45 1224 6687
Fax
+98 45 1224 6687
Email
m.rostami@arums
Web page address
www.arums.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)