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IRCT20240711062393N1 IRCT 2024-07-25 Mazandaran University of Medical Sciences Efficacy Evaluation of Nano-Luliconazole in Patients with Treatment-Resistant Dermatophytosis Efficacy Evaluation of Loaded Nanostructured Lipid Carriers (NLC) with Luliconazole in Treatment-Resistant Dermatophytosis 2024-08-10 anticipated 75 Complete https://irct.ir/trial/77900 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: randomization The block method will be used for randomization. This will be performed using Random allocation software. To ensure unpredictability, the software will calculates block number and size. Based on numbers produced by the software, samples are assigned to groups, Blinding description: Simultaneously, the participants receive information regarding conducting a research study and complete the consent form; however, the type of luliconazole gel (simple or nano form) will remain concealed from her. 1 Dermatophytosis is an inflammatory skin infection caused by dermatophyte fungi including Trichophyton, Microsporum, Epidermophyton, Lophophyton, Nannizzia, Parathion, and Arthroderma.. Intervention 1: Intervention group: The first group includes patients resistant to dermatophytosis other than onychomycosis who take NLC gel loaded with luliconazole. Intervention 2: Intervention group: The second intervention group: patients resistant to dermatophytosis other than onychomycosis also receive itraconazole along with luliconazole. Yes - There is a plan to make this available What will be shared: Contributors' data in the study is shareable once it is unidentifiable. When: The access period begins six months after the results are published. To whom: researchers who are working at universities Conditions: This information is only for comparison with similar research." Where to obtain: "The information provided is only intended for comparison with similar research." How to obtain: Project data sets will be housed on the Web site and/or the file transfer protocol site created for the study, and all data sets will be password-protected. Project Principal Investigators will have direct access to their own site’s data sets, and will have access to other sites' data by request. To ensure confidentiality, data dispersed to project team members will be blinded of any identifying participant information Comments:
public Mahdi Abastabar
Sari, Imam Square (RA) - Juibar Road, the beginning of Valiasr Highway (AJ), Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3304 4000 mabastabar@gmail.com Mazandaran University of Medical Sciences scientific Mahdi Abastabar
Sari, Imam Square, Juibar road, the begining of Valiasr roadway, Mazandararn University of Medical Sciences
Sari Iran (Islamic Republic of) ۴۸۱۵۷۳۳۹۷۱ +98 11 3304 4000 ravabetomoomi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) patients with treatment-resistant dermatophytosis 20 years no limit Both Neonates and children range from 0 to 19 years pregnant mothers B35 Dermatophytosis Treatment - Drugs Treatment - Drugs Intervention group: The first group includes patients resistant to dermatophytosis other than onychomycosis who take NLC gel loaded with luliconazole. Intervention group: The second intervention group: patients resistant to dermatophytosis other than onychomycosis also receive itraconazole along with luliconazole. Individuals with treatment-resistant dermatophytosis. Timepoint: Patients are evaluated after 2 and 4 weeks of treatment. Method of measurement: Assessing improvement, lesion size, itch, and inflammation based on the questionnaire's scoring. Mazandaran University of Medical Sciences Approved 2024-05-14 Ethics committee of Mazandaran University of Medical Sciences Moalem square Sari Mazandaran Iran (Islamic Republic of)