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IRCT20240923063136N3 IRCT 2025-04-25 Kermanshah University of Medical Sciences Evaluating effectiveness of an antifungal gel in patients with tinea corporis Evaluating the effectiveness of a silicone gel containing antifungal compounds in patients with tinea corporis 2025-10-22 anticipated 100 Recruiting https://irct.ir/trial/82732 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with a block size of 4 will be used for the two groups. A third person who is not involved in the patient recruitment and evaluation process will create the random sequence using the Research Randomizer. Each patient will be given a unique code that can be generated on this site. Therefore, the individuals involved in the study will not know which group the next person will be assigned to, nor will they be aware of the random sequence; only the statistical consultant will have knowledge of the random sequence, and the codes will remain with him, Blinding description: Blinding is not possible because Lamisil is a cream and differs from silicone gel in its appearance . The statistical consultant who provided the data analysis is aware of the groups and codes. The person evaluating the results is not aware of the codes. 2 Skin fungal infection. Intervention 1: Intervention group 1 will receive silicone gel containing two antifungal compounds, terbinafine and thymol. The amount of terbinafine is 1% and the amount of thymol is 3%. This is the gel that we plan to prepare during our experiments (at Faculty of Pharmacy, Kermanshah University of Medical Sciences). Duration of application will be two weeks, applied to the site of infection every day, twice a day. Outcomes will be assessed on day 0 (before the start of the interventions) and day 15 (the day after the end of the interventions). Intervention 2: Control group: In this group, patients receive commercially available terbinafine 1% cream (Lamisil, NOVARTIS Co). Duration of application will be two weeks, applied to the site of infection every day, twice a day. Outcomes will be assessed on day 0 (before the start of the interventions) and day 15 (the day after the end of the interventions). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Cyrus Jalili
University street, Parastar Blvd.
Kermanshah Iran (Islamic Republic of) 6714869914 +98 38 3835 8943 cjalili@kums.ac.ir Kermanshah University of Medical Sciences scientific Sara Darakhshan
University Street, Parastar Blvd.
Kermanshah Iran (Islamic Republic of) ۶۷۱۴۴۱۴۹۷۱ +98 83 3427 8990 darakhshan.sara@gmail.com Razi University Iran (Islamic Republic of) Patients who have been ill for fewer than 7 days will be included in the study. All patients who are positive for dermatophyte filaments on 10% KOH mount and have less than 20% of their body surface area involved will be included in the study. No other skin disease should be reported. Erythema, scaling rash, and itching should be at least 2 numbers. 18 years 75 years Both Patients with diabetes, HIV, diseases and immune system problems will not be included in the study. Patients with a history of hypersensitivity reactions to terbinafine were not included in the study. Individuals who are using topical or systemic corticosteroids, antibiotics, or antifungal treatments, or have used them within four weeks prior to the start of the study, will not be included in the study. Pregnant, lactating women, or those planning to become pregnant were not included in the study. B35.4 Tinea corporis Treatment - Drugs Treatment - Drugs Intervention group 1 will receive silicone gel containing two antifungal compounds, terbinafine and thymol. The amount of terbinafine is 1% and the amount of thymol is 3%. This is the gel that we plan to prepare during our experiments (at Faculty of Pharmacy, Kermanshah University of Medical Sciences). Duration of application will be two weeks, applied to the site of infection every day, twice a day. Outcomes will be assessed on day 0 (before the start of the interventions) and day 15 (the day after the end of the interventions). Control group: In this group, patients receive commercially available terbinafine 1% cream (Lamisil, NOVARTIS Co). Duration of application will be two weeks, applied to the site of infection every day, twice a day. Outcomes will be assessed on day 0 (before the start of the interventions) and day 15 (the day after the end of the interventions). Symptoms of fungal infection. Timepoint: Before intervention (day 0), and after intervention (day 15). Method of measurement: Potassium hydroxide (KOH) preparation test. Erythema at the site of infection. Timepoint: Before intervention (day 0), and after intervention (day 15). Method of measurement: Visual assessment. Scaling at the site of infection. Timepoint: Before intervention (day 0), and after intervention (day 15). Method of measurement: Visual assessment. Burning/itching sensation at the site of infection. Timepoint: Before intervention (day 0), and after intervention (day 15). Method of measurement: visual analogue scale (VAS). Kermanshah University of Medical Sciences Approved 2025-01-27 Ethics committee of Kermanshah University of Medical Sciences University Street, Parastar Blvd. Kermanshah Kermanshah Iran (Islamic Republic of)