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IRCT20260502069237N1 IRCT 2026-08-25 Bojnourd University of Medical Sciences Comparison of the effect of clotrimazole nanogel and clotrimazole in the treatment of dermatophytosis Comparison of the effects of clotrimazole and clotrimazole nanogel in patients with skin complications caused by dermatophytosis. 2026-08-28 anticipated 124 Recruiting https://irct.ir/trial/89897 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Dermatophytosis. Intervention 1: Intervention group: Patients in the group treated with the 1% clotrimazole nanogel prepared in this study are assigned. Intervention 2: Control group: Patients in the group treated with 1% commercially available clotrimazole ointment are assigned. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the confidentiality of participants' data and images, the publication of patients' information and images is not possible.
public Yaghoub Yazdani
No. 21, West Taleghani Street, Hejrat Street, 26 Hejrat Street, bojnourd town
Bojnourd Iran (Islamic Republic of) 9419678675 +98 58 3222 0579 yazdaniyaghoub911@gmail.com Bojnourd University of Medical Sciences scientific Amir Amani
Shahriar street
Bojnourd Iran (Islamic Republic of) 9417694735 +98 58 3229 7157 amani76@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of dermatophytosis Laboratory diagnosis of dermatophytosis 18 years 60 years Both Pregnancy Patients with immunodeficiency Patients receiving immunosuppressive agents L30.3 Infective dermatitis Treatment - Drugs Treatment - Drugs Intervention group: Patients in the group treated with the 1% clotrimazole nanogel prepared in this study are assigned. Control group: Patients in the group treated with 1% commercially available clotrimazole ointment are assigned. Extent of skin lesions caused by dermatophyte fungi. Timepoint: 14 days. Method of measurement: A direct measurement protocol for lesion dimensions using a ruler is employed, which is described in various articles as a rapid and useful method. In this method, lesion length and width are measured, and the lesion area during treatment is calculated using the formula A = 0.73 × L × W. Bojnourd University of Medical Sciences Approved 2026-04-19 North Khorasan University of Medical Sciences No. 21, West Taleghani Street, Hejrat Street, 26 Hejrat Street, bojnourd town Bojnourd North Khorasan Iran (Islamic Republic of)