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IRCT20230816059161N1 IRCT 2023-12-25 Shiraz University of Medical Sciences Investigating the effect of DermatoTreat spray in the treatment of dermatophytosis Investigating the effect of film-forming spray containing terbinafine (DermatoTreat) in the dermatophytosis treatment, A randomized double-blind clinical trial 2023-11-06 anticipated 98 Complete https://irct.ir/trial/72065 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: An independent investigator, not directly involved in the trial, performed the randomization using permuted randomized blocks created by the software (block size = 4). Allocation concealment will also be performed by an independent investigator using sequentially numbered sealed, opaque envelopes, Blinding description: Patients and physicians will be blinded to treatment group assignment throughout the study. Patients in the treatment group will be treated with an effective spray and an ineffective ointment, and patients in the control group will be treated with an effective ointment and an ineffective spray. The appearance, size, color and smell of ointments and sprays will be completely similar in both groups. 3 Dermatophytosis. Intervention 1: Intervention group: treatment with DermatoTreat spray. Patients receive the developed Dermatotrit spray containing 1% Terbinafine Hydrochloride manufactured by Parsa Biotechnology Biotechnology Company for daily topical treatment (twice a day) for 4 weeks. Intervention 2: Control group: Treatment with the standard Terbinafine cream 1%. Patients receive terbinafine ointment 1% (under the trade name Binafin 1%) manufactured by Tehran Chemical Factory for daily (twice) topical treatment for 4 weeks. Yes - There is a plan to make this available What will be shared: The obtained results will be published in the form of articles and specialized congresses. When: One year after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Data can be obtained for the purpose of health promotion after sending a written request from the principal investigator. Where to obtain: A written request for access to information should be sent to the email of the corresponding author or principal investigator.( Dr. Kamiar Zomorodian, zomorodian@sums.ac.ir) How to obtain: The request will be reviewed by the main researcher and if approved, will be sent to the applicant. Comments:
public Kamiar Zomorodian
School of Medicine, Shiraz University of Medical Science, Emam Hosein square, Karim khan Zand Ave.
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3230 5887 zomorodian@sums.ac.ir Shiraz University of Medical Sciences scientific Kamiar Zomorodian
School of Medicine, Shiraz University of Medical Science, Emam Hosein square, Karim khan Zand Ave.
Shiraz Iran (Islamic Republic of) 7134845794 +98 71 3230 5887 zomorodian@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) All the dermatophytosis patients who were diagnosed by physical exam by doctor or by routine mycological methods Availability for the duration of the study (6 weeks) Male or female, 18 years or older Willingness to follow the study protocol Not taking systemic antifungal drugs in the last month Not using topical anti-fungal drugs or anti-fungal shampoo in 2 weeks before treatment Insensitivity to terbinafine Informed consent 18 years no limit Both Moccasin-type tinea pedis Tinea capitis , tinea with an area of more than 20% of the body Tinea resistant to previous treatments including oral treatment and Tinea incognito Severe maceration of interdigital spaces Severe fissuring Prescribing or taking oral antifungal medication in the two weeks before or during the study History of dry feet, cracks, fissures Concomitant onychomycosis Serous discharge or pus Concomitant immunosuppressive or antimicrobial therapy Failure to respond to treatment Drug allergy Failure to cooperate with the doctor Pregnant and lactating women B35 Dermatophytosis Treatment - Drugs Treatment - Drugs Intervention group: treatment with DermatoTreat spray. Patients receive the developed Dermatotrit spray containing 1% Terbinafine Hydrochloride manufactured by Parsa Biotechnology Biotechnology Company for daily topical treatment (twice a day) for 4 weeks. Control group: Treatment with the standard Terbinafine cream 1%. Patients receive terbinafine ointment 1% (under the trade name Binafin 1%) manufactured by Tehran Chemical Factory for daily (twice) topical treatment for 4 weeks. Effective treatment (fungal treatment and minimal symptoms). Timepoint: In the beginning, 1, 2 and 4 weeks after the initiation of therapy. Method of measurement: Microscopic examination (direct smear exam) and clinical evaluation that is based on a total of 6 symptoms (skin peeling, vesiculation, erythema, fissure, soaking and itching) which is recorded by the physician. The amount of side effects. Timepoint: In the beginning, 1, 2 and 4 weeks after beginning of therapy. Method of measurement: To check the safety of the treatment, we will calculate the amount of side effects as well as serious side effects and compare them between the two arms of the study using chi-square tests to check if there is a statistically significant difference or not. Effective treatment (fungal treatment and minimal symptoms). Timepoint: 4 weeks after beginning of therapy. Method of measurement: Negative mycological microscopic test (direct) and clinical evaluation that is based on a total of 6 symptoms (skin peeling, vesiculation, erythema, fissure, soaking and itching) which is recorded by the doctor. Patient satisfaction score. Timepoint: At the end of the treatment period. Method of measurement: Patients complete a short survey in the form of a questionnaire about their perception of the tolerability, effectiveness and comfort of the treatment on a five-point scale, where 1 = poor, 2 = fair, 3 = good, 4 = very good, 5 = great, or they may respond with "no answer/prefer not to say". Scores for each treatment will be calculated and compared. Self-reported patient compliance. Timepoint: At the end of the treatment period. Method of measurement: In the questionnaire, patients are asked to estimate how many doses they have missed. Possible answers include none, 1-2, 3-4, 5-6, 7-8, or 9 or more. It shows whether there is a significant difference in the probability of adherence of patients to a treatment regimen or not. Mazandaran University of Medical Sciences Shiraz University of Medical Sciences Mazandaran University of Medical Sciences Approved 2023-08-29 Iran National Committee for Ethics in Biological Research Shiraz University of Medical Science, Karim Khan Zand Ave. Shiraz Fars Iran (Islamic Republic of)