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IRCT20120707010203N10 IRCT 2021-01-03 Mazandaran University of Medical Sciences Treatment effect of topical fluconazole nanoparticles on Tinea versicolor Evaluation of Fluconazole-NLC nano emulgel (0.5%) effect on Tinea versicolor in comparison with clotrimazole cream 2016-04-20 anticipated 60 Complete https://irct.ir/trial/49284 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control using simple randomization and patients will divide to intervention or control group based on their code. Randomization list will be prepared by online tool (https://www.random.org/lists) and sealed envelope will be used for concealment, Blinding description: The fluconazole nano emulgel and clotrimazole cream will package in similar packaging. The preparations are similar in color and odor. The clinical researcher and patients will not be aware of the administered preparation. 2 Tinea versicolor. Intervention 1: Intervention group: Fluconazole nanoparticles (NLC) emulgel 0.5%, will be prepared in faculty of pharmacy and will be formulated as nano-emulgel 0.5%. The preparations will be packaged and receive code label, after physicochemical and microbial control. The patients will receive Fluconazole nano-emulgel twice daily for 8 months. They will not receive any other medication in this period of time. Intervention 2: Control group: Topical clotrimazole cream 1% (Pars Darou Co.) will be packaged in similar tubes to Fluconazole nano-emulgel and will be labeled by definite code. The patients will receive preparation twice/day for 8 months. They will not receive any other medication in this period of time. No - There is not a plan to make this available Justification or reason for not sharing IPD is it is secret
public Majid Saeedi
Faculty of Pharmacy, 18th. Km of khazar road,
Sari Iran (Islamic Republic of) 4817844718 +98 11 3354 3084 msaeedi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Majid Saeedi
Deputy of Research and Technology, Moallem Sq.
Sari Iran (Islamic Republic of) 4817844718 +98 11 3354 3081 msaeedi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Clinical feature of Tinea versicolor Positive Smear test 5 years no limit Both Liver disease Nephrotic disorders Diabetes Malignant disease Pregnancy Breast feeding anti-fungal treatment in recent one months Sore or damage in infected area B36.0 Pityriasis versicolor Treatment - Drugs Treatment - Drugs Intervention group: Fluconazole nanoparticles (NLC) emulgel 0.5%, will be prepared in faculty of pharmacy and will be formulated as nano-emulgel 0.5%. The preparations will be packaged and receive code label, after physicochemical and microbial control. The patients will receive Fluconazole nano-emulgel twice daily for 8 months. They will not receive any other medication in this period of time. Control group: Topical clotrimazole cream 1% (Pars Darou Co.) will be packaged in similar tubes to Fluconazole nano-emulgel and will be labeled by definite code. The patients will receive preparation twice/day for 8 months. They will not receive any other medication in this period of time. Skin lesion area. Timepoint: At the beginning of study (time zero) and 2, 4 and 8 weeks after treatment. Method of measurement: Clinical evaluation and smear test. Mazandaran University of Medical Sciences Approved 2014-09-21 Ethics committee of Mazandaran University of Medical Sciences Deputy of Research and Technology building, Moallem sq., Sari, Iran Sari Mazandaran Iran (Islamic Republic of)