IRCT20240711062393N2 IRCT 2025-06-07 Mazandaran University of Medical Sciences Evaluation of the effect of nanoliposomal amphotericin B in the treatment of patients with resistant dermatophytosis Determining the efficacy of topical nanoliposomal amphotericin B in individuals with treatment-resistant dermatophytosis. 2025-07-23 anticipated 75 Complete https://irct.ir/trial/82670 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Randomization For randomization, the block randomization method will be used. Participants are divided into small blocks (e.g., 4 or 6 individuals per block), with an equal number assigned to each group within each block. In this study, the unit of randomization is individual, as each patient is independently assigned to one of the groups. The Random Allocation software is used to generate the random sequence. Implementation mechanism: The block size and number of blocks are determined randomly and unpredictably by the software. After generating the sequence, patients are assigned to different groups based on the produced numbers. Single-Blinding Participants are unaware of which group they are in (nanosomal amphotericin B + itraconazole vs. nanosomal amphotericin B alone). Researchers and assessors are aware of the treatment type. Allocation Concealment To prevent selection bias, it must be ensured that researchers are unaware of future patient assignments before enrollment. Methods include: Sealed opaque envelopes: Random numbers are placed in sealed, non-transparent envelopes. Electronic system: The Random Allocation software determines the treatment group only after patient registration. In this study: The software is used, so allocation remains concealed until the moment of patient enrollment, Blinding description: Simultaneously, the participants receive information regarding conducting a research study and complete the consent form; however, the type of gel (simple or nano form) will remain concealed from her. 3 Dermatophytosis is an inflammatory skin infection caused by dermatophyte fungi including Trichophyton, Microsporum, Epidermophyton, Lophophyton, Nannizzia, Parathion, and Arthroderma.. Intervention 1: Group 1: Patients with treatment-resistant dermatophytosis (non-onychomycosis) who will receive nanoliposomal amphotericin B. Sina Ampholish 0.4% ointment is used twice a day for 4 weeks. Intervention 2: Group 2: Patients with treatment-resistant dermatophytosis, non-onychomycosis, who will receive nanoliposomal amphotericin B and itraconazole. Sina Ampholish 0.4% ointment is used twice a day, and itraconazole 200 mg tablet is taken once a day for 4 weeks. Intervention 3: Control group: Patients with treatment-resistant dermatophytosis (non-onychomycosis) who will receive itraconazole (200 mg per day for 4 weeks) will serve as the control group. 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 website 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 access to other sites' data by request. To ensure confidentiality, data dispersed to project team members will be blinded to any identifying participant information Comments: