A survay in effectiveness of ketoconazole shampoo versus climbazole shampoo in treatment of tinea versicolor
Design
The study is a single_blind , randomized clinical trial with control group and parallel group design.
Settings and conduct
This is a randomized single_blind clinical trial study.sixty patients with tinea versicolor and limited skin involvement over 12 years old of both sexes,attending Afzalipour hospital in Kerman enrolled the study. Patients were allocated to 2 groups ( intervention and control) .intervention group will receive climbazole 2% shampoo and the control group will receive ketokonazole 2% shampoo.
Participants/Inclusion and exclusion criteria
"Inclusion criteria:" All patients with tinea versicolor with limited skin involvement that dose not require systemic treatment."Exclusion criteria": history of systemic underlying disease, history of allergy to climbazole, Pregnancy or lactation and Taking any topical or systemic anti fungal drug since the onset of the disease.
Intervention groups
Patients in control group were received Ketokonazole 2% shampoo "Iran Najo Company " (three days a week for three weeks and stay on the body ten minutes for foam shampoo)
and in intervention group climbazole 2% shampoo "Asaderm Company" (three days a week for three weeks and stay on the body ten minutes for foam shampoo),respectively.
Main outcome variables
Fluorescence of lesions with Woods lamp , Mycological smear KOH of lesions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190811044510N1
Registration date:2019-11-07, 1398/08/16
Registration timing:retrospective
Last update:2019-11-07, 1398/08/16
Update count:0
Registration date
2019-11-07, 1398/08/16
Registrant information
Name
ziba omidvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 8236
Email address
z.omidvand@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey in effectiveness of ketoconazole versus climbazole shampoo in the treatment of tinea versicolor .
Public title
Evaluation of the effectiveness of climbazole shampoo treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with tinea versicolor
Limited skin disease that does not require systemic treatment
Exclusion criteria:
Underlying systemic disease
Pregnancy and lactation
Taking any topical or systemic antifungal drug since the onset of the disease
history of allergy to climbazole
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For each person, a random number is selected from random number table with the help of mini tab16 software. If the number was odd, person falls into group A, and if the number was Even, person falls into group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient are assigned to two groups A and B,randomly,and researcher who visits and evaluates patients and Also,the person who analyzes the data is not aware of these codes.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences.
Street address
University of Medical Science Paradist , The begining of the axisof the seven Alavi garden.
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2018-12-25, 1397/10/04
Ethics committee reference number
]IR.KMU.AH.REC.1397.107
Health conditions studied
1
Description of health condition studied
tinea versicolor
ICD-10 code
B36.0
ICD-10 code description
Pityriasis versicolor
Primary outcomes
1
Description
fluorescence of lesion
Timepoint
At the beginning of the study ( before intervention) ,4 weeks and 12 weeks after intervention.
Method of measurement
wood lamp
2
Description
effectiveness based on mycological smear KOH
Timepoint
At the beginning of the study ( before intervention) ,4 weeks and 12 weeks after intervention.
Method of measurement
Lab evaluation of KOH smear
Secondary outcomes
1
Description
Patients symptoms( example :itching ,color variation and scaling)
Timepoint
At the beginning of the study (before intervention), 4 weeks and 12 weeks after intervention.
Method of measurement
Clinical examination through observation
Intervention groups
1
Description
Intervention group: patients are treated with shampoo climbazole 2%(Asaderm company)for 3 weeks ,3 days a week and do not wash the foam for 10 minutes.
Category
Treatment - Drugs
2
Description
Control group: Intervention group: patients are treated with shampoo ketoconazole 2%(iran najo company)for 3 weeks ,3 days a week and do not wash the foam for 10 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Afzalipour Hospital.
Full name of responsible person
Ziba Omidvand
Street address
Afzali Hospital,Emam Highway.
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8237
Email
z.omidvand@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
Ebne sina Avenue,Jehad Blvd
City
Kerman
Province
Kerman
Postal code
7619613159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Annually grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Ziba Omidvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Afzali Hospital ,Emam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8237
Email
z.omidvand@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Rezvan Amiri
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Afzali Hospital,Emam Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
0098 34 3222250
Email
r_amiri@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ziba Omidvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Afzali Hospital , Emam Highway,
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8237
Email
z.omidvand@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available