comparing efficacy of niosomal climbazole cream and niosomal ketoconazole cream in treatment of tinea versicolor
Design
two arms,parallel groups,randomized controlled,triple blind clinical trial
Settings and conduct
The study will be done on 40patients visited at Afzalipour hospital. patient will be randomly allocated into two arms and will receive niosomal climbazole cream and niosomal ketoconazole cream twice daily for 3weeks.
Participants/Inclusion and exclusion criteria
inclusion criteria:patient at least 12 years old
Exclusion criteria:patient with another cutaneous or systemic disease,history of hypersensitivity to ketoconazole or climbazole,using topical or systemic antifungal and corticosteroides drug in the previous 4weeks,using og other antifungal shampoo(selenium sulfide,pyrithine zink),pregnancy,breastfeeding
Intervention groups
Intervention group :niosomal climbazole cream twice daily for 3weeks.
control group :niosomal ketoconazole cream twice daily for 3weeks.
Main outcome variables
severity of tinea versicolor lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200725048196N1
Registration date:2021-05-02, 1400/02/12
Registration timing:prospective
Last update:2021-05-02, 1400/02/12
Update count:0
Registration date
2021-05-02, 1400/02/12
Registrant information
Name
Fateme Rostami nasab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4321 0043
Email address
frn1368@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-11-06, 1400/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing effectiveness of niosomal ketoconazole cream versus niosomal climbazole cream in treatment of tinea versicolor patient
Public title
Assessing effectiveness of niosomal ketoconazol cream versus niosomal climbazol cream in tinea versicolor patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A diagnosis of tinea versicolor made by the attending dermatologist who first visit patient at Afzalipour hospitals dermatology clinic
Filling out and signing the written informed consent form by the patient
patients age at least 12 years old
Male or nonpregnant and nonbreastfeeding female
Exclusion criteria:
Any dermatologic or systemic disorders
History of hypersensitivity to ketoconazole or climbazole
Using systemic or topical antifungal drugs or crticosteroides during the 4weeks perior immediatly before starting the trial
Using other antifungal shampoo( selenium sulfide,pyrithione zink)
pregnancy or breastfeeding
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
using table of random numbers,20patients will be allocated to each of the intervention and control groups.
each patient will be given a number from 1 to 40.one row and one column will be randomly chosen from the table of random number.the intersection between this row and column will be the starting point of sampling.a finger will be put on the starting point and will be moved downwards through the table .the moving of the finger will be repeated until 20 parcipitants of intervention group will be chosen.duplicate numbers and numbers larger than 40 will not be considered.the remaining 20 parcipitants will be automatically put in the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
letters A or B (niosomal climbazole cream and niosomal ketoconazole cream)will be allocated to each treatment arm .the only person aware of what treatment is specified to each of the groups will be the operator who responsible for handling in the treatment to the patients. patients,physicians and the analyzer of the final data will not be aware of the content of group A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical sciences
Street address
Kerman University of Medical Science, Medical university campus, Haftbagh highway ,Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
IR.KMU.AH.REC.1399.076
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
Tinea versicolor lesion severity
Timepoint
At base line and 4,12 weeks later
Method of measurement
severity of lesion( scalling,pruritus,erythema,hyperpigmentation ,hypopigmentation)
Secondary outcomes
1
Description
treatment side effect
Timepoint
throughout study periode and up to 3months after the start of the study
Method of measurement
history taking and physical exam
Intervention groups
1
Description
Intervention group: will recive topical niosomal climbazol cream0.5%(will be made by pharmacy research center of Kerman university of Medical Science) to be used twice daily for 3weeks.
Category
Treatment - Drugs
2
Description
Control group: will recive niosomal ketoconazole cream2% (will be made by pharmacy research center of Kerman university of Medical Science)to be used twice daily for 3weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzali pour Hospital dermatology clinic
Full name of responsible person
Rezvan Amiri
Street address
Afzalipour hospital,Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
rezvanamiri1358@yahoo.com
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,Jahad Blvd
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3855
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Rezvan Amiri
Position
Assistant professor of dermatology
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Afzalipour hospital,Imam highway
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
rezvanamiri1358@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fateme Rostami nasab
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Afzalipour hospital,Imam highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Frn1368@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fateme Rostami nasab
Position
Dermatology resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Afzalipour hospital, Imam highway
City
Kerman
Province
Kerman
Postal code
7616913911
Phone
+98 34 3132 8000
Email
Frn1368@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available