Comparison of the effects of clotrimazole and clotrimazole nanogel in patients with skin complications caused by dermatophytosis.

The aim of this study is to compare the effect of clotrimazole and clotrimazole nanogel on skin lesions caused by dermatophytes and Malassezia species in patients referred to Imam Reza Hospital in Bojnourd in the year 1405-1406, in which we will compare the effect of commercially available clotrimazole and the synthesized nanogel.

A clinical trial with a control group, with parallel groups, triple-blind, randomized, phase 3 on 124 patients. Block randomization was used for randomization.

Patients with skin lesions caused by dermatophyte and Malassezia fungi, referred to the dermatology clinic of Imam Reza Hospital in Bojnourd, who are enrolled in the study by a dermatologist.

Main inclusion criteria: clinical diagnosis of dermatophyte, laboratory diagnosis of dermatophyte / Main exclusion criteria: pregnancy, immunocompromised patients, patients using immunosuppressive medications.

After confirmation of fungal infection by the laboratory, patients are divided into two groups: · The first group is prescribed 1% commercially available ointment. · The second group is prescribed 1% clotrimazole nanogel prepared in this study. Subsequently, patients are asked to refer to the dermatology clinic at specified times after using the ointment and nanogel for evaluation of the lesion by a dermatologist. Subsequently, the dermatologist measures and compares the degree of improvement in relation to clotrimazole ointment and nanogel during consecutive patient visits, and ultimately, the efficacy of these two medications will be compared.

Photographic modality: Lesion extent, lesion thickness, lesion color

Block randomization was used for randomization. We will use blocks of size 4, consisting of 2 A's and 2 B's. The possible permutations are: AABB, ABAB, ABBA, BAAB, BABA, BBAA. We need 62 patients for A and 62 for B, totalling 124 patients. We need $124/4= 31$ blocks. To distribute the permutations as evenly as possible: $31/div 6= 5$ with a remainder of 1. So, 5 permutations will appear 5 times, and 1 permutations will appear 6 times.

After the preparation of clotrimazole nanogel and the purchase of clotrimazole ointment by the student researcher, each is packaged in completely identical and uniform containers. Prior to allocation to patients, block randomization is performed. Then, a professor who was involved in the preparation of the drug and does not participate in the conduct of the clinical trial divides the containers into two groups, A and B, based on the random sequence. The medications are randomly distributed among patients. Only that professor knows which group contains the clotrimazole nanogel and which contains the clotrimazole ointment.

Due to the confidentiality of participants' data and images, the publication of patients' information and images is not possible.

The clinical study documents, including the informed consent form and the clinical study report. These documents provide information on the objectives and methods of conducting the study, interventions, outcome assessment, ethical considerations, confidentiality of information, the voluntary nature of participation, and the participants' right to withdraw from the study, in accordance with research ethics requirements and clinical trial registration standards.

At least one year after the end of the study

Yaghoub Yazdani Dr. Amir Amani Dr. Abozar Nasiri Jahrodi Dr. Amir Abbas Peymanfar

Due to the confidentiality of patients' information and images, access to the data is not possible for anyone except the supervisors, the advisor, and the responsible student.

Dr. Amir Amani Dr. Abozar Nasiri Jahrodi

A message shall be sent to the email addresses of the advisors listed below, and one should await their response: amani76@gmail.com Nasir30a@gmail.com