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IRCT20200725048196N1 IRCT 2021-05-02 Kerman University of Medical Sciences Assessing effectiveness of niosomal ketoconazol cream versus niosomal climbazol cream in tinea versicolor patient comparing effectiveness of niosomal ketoconazole cream versus niosomal climbazole cream in treatment of tinea versicolor patient 2021-05-05 anticipated 40 Complete https://irct.ir/trial/55651 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2-3 Tinea versicolor. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is because its not necessary.
public Rezvan Amiri
Afzalipour hospital,Imam highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5856 rezvanamiri1358@yahoo.com Kerman University of Medical Sciences scientific Fateme Rostami nasab
Afzalipour hospital,Imam highway
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3132 8000 Frn1368@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) 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 12 years no limit Both 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 B36.0 Pityriasis versicolor Treatment - Drugs Treatment - Drugs 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. 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. Tinea versicolor lesion severity. Timepoint: At base line and 4,12 weeks later. Method of measurement: severity of lesion( scalling,pruritus,erythema,hyperpigmentation ,hypopigmentation). 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. Kerman university of medical sciences Approved 2021-01-31 Research Ethics Committee of Kerman University of Medical sciences Kerman University of Medical Science, Medical university campus, Haftbagh highway ,Kerman Kerman Kerman Iran (Islamic Republic of)