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IRCT20240225061105N1 IRCT 2024-03-04 Kermanshah University of Medical Sciences Comparison of the Effect of Terbinafine alone with the Combination of Terbinafine and Prednisolone in the Treatment of Inflammatory Tina Capitis Comparison of the Effect of Terbinafine alone with the Combination of Terbinafine and Prednisolone in the Treatment of Inflammatory Tina Capitis 2023-11-15 anticipated 40 Complete https://irct.ir/trial/75726 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this interventional study, patients referred to Hajdaiee dermatology clinic who are clinically suspected of inflammatory tinea capitis and are confirmed through para-clinical assessment are included in the study. Patients are randomly assigned to two groups receiving Terbinafine plus placebo and receiving Terbinafine plus Prednisolone, as first and second groups, respectively. Blocks of 4 (10 blocks) will be produced by the software by the statistical consultant. The registration of people is done by the dermatology assistant. People are assigned to two groups by the secretary of the group. The follow-up of the treatment results is done by a dermatologist who does not know about the allocation of people.The concealment mechanism is done by placing the blocks in the sealed envelopes, which is at the disposal of the secretary. Photo of the patients is taken at the beginning, during and at the end of the treatment. Patients are followed up initially weekly for up to 4 weeks, then monthly for up to 4 months in terms improvement, hair regrowth and possible complications. Treatment outcome will be reviewed by an independent dermatologist. Information and treatment results are recorded in patients' files and analyzed by appropriate statistical methods, Blinding description: The Patient and the Data Assessor (A Dermatologist who does not know the Allocation of Subjects) are blinded. 2 Condition 1: Inflammatory Tinea Capitis. Condition 2: Kerion. Intervention 1: First Intervention group: This group receives Terbinafine plus placebo. Based on the patient's weight, less than 25 kilograms 125 mg, between 25-45 kilograms 187.5 mg, and more than 45 kilograms 250 mg will be prescribed oral Terbinafine tablets (Binafine, Tehran Chemical Company) for four weeks. Intervention 2: Intervention group: This group receives combined treatment of Terbinafine and Prednisolone. Based on the patient's weight, less than 25 kilograms 125 mg, between 25-45 kilograms 187.5 mg, and more than 45 kilograms 250 mg will be prescribed oral Terbinafine tablets (Binafine, Tehran Chemical Company) for four weeks. For Prednisolone, for less than 10 years, 2.5 mg and for more than 10 years, 5 mg will be prescribed for 4 weeks. Yes - There is a plan to make this available What will be shared: Information about the main outcome can be shared after de-identifying individuals. When: Immediately after printing the results. To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Analysis on data related to age, sex, location of lesion and occupation of patients is allowed for retrospective studies. Where to obtain: Dr. Soheila Azmoodeh, Dermatology Resident, Kermanshah University of Medical Sciences, Haj Daei Dermatology Clinic: Golestan Crossroad, Kermanshah, soheilaazmoodeh88@gmail.com 00989113582535 Dr. Hossein Kavousi, Dermatologist, Kermanshah University of Medical Sciences, Haj Dai Dermatology Clinic: Kermanshah, Golestan Crossroads, hkavousi@gmail.com 00989181322243 How to obtain: The requester can request to receive data through email. It will receive the data after 2 days. Comments:
public Soheila Azmoodeh
Haj Dayi Clinic , Golestan Crossroads , Kermanshah
Kermanshah Iran (Islamic Republic of) 6714653113 +98 11 3463 3338 soheilaazmoodeh88@gmail.com Kermanshah University of Medical Sciences scientific Hosein.Kavoussi
Haj Dai skin specialist clinic , Golestan intersection , Kermanshah
Kermanshah Iran (Islamic Republic of) 6714653113 +98 83 3845 3486 hkavoussi@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) All Patients with Inflammtory Tinea Capitis that have been confirmed Clinically and by Smear and Culture. no limit no limit Both Patients who have Previosly recieved Corticosteroids Patients with Immune System Deficiency Pregnancy Breastfeding Diabetic patient Treatment - Drugs Treatment - Drugs First Intervention group: This group receives Terbinafine plus placebo. Based on the patient's weight, less than 25 kilograms 125 mg, between 25-45 kilograms 187.5 mg, and more than 45 kilograms 250 mg will be prescribed oral Terbinafine tablets (Binafine, Tehran Chemical Company) for four weeks. Intervention group: This group receives combined treatment of Terbinafine and Prednisolone. Based on the patient's weight, less than 25 kilograms 125 mg, between 25-45 kilograms 187.5 mg, and more than 45 kilograms 250 mg will be prescribed oral Terbinafine tablets (Binafine, Tehran Chemical Company) for four weeks. For Prednisolone, for less than 10 years, 2.5 mg and for more than 10 years, 5 mg will be prescribed for 4 weeks. Scar rate. Timepoint: Before treatment and four months after treatment. Method of measurement: photo. اسکور پاسخ به درمان ضد التهابی. Timepoint: Before treatment and 2 months after treatment. Method of measurement: Questionnaire: Based on the clinical symptoms of redness, edema, pustule, scaling, itching, pain and hair loss, it will be scored. Scoring will be done from a minimum score of 0 to a maximum score of 7. Kermanshah University of Medical Sciences Approved 2023-11-14 Ethics committee of Kermanshah University of Medical Sciences No. 57, Agha Razi Alley, Golestan Crossroads, Kermanshah Kermanshah Kermanshah Iran (Islamic Republic of)