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IRCT20220117053747N2 IRCT 2022-03-25 Tabriz University of Medical Sciences Comparison of therapeutic, immunity and efficacy of topical hydrogen peroxide solution (40% vol) with cryotherapy in seborheic keratosis. Comparison of therapeutic, immunity and efficacy of topical hydrogen peroxide solution (40% vol) with cryotherapy in seborheic keratosis. 2022-01-22 anticipated 90 Complete https://irct.ir/trial/61432 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Data collection method: The data obtained will be recorded by a data collection form designed by the researcher. Data analysis method: The data obtained by SPSS statistical analysis software version 21 will be statistically analyzed, Randomization description: Patients will be randomly assigned to an outpatient file number and a table of random numbers to two intervention and control groups will be divided. Random number table is a set of numbers that are produced without a specific pattern or order and in a completely random manner and has become a table. In order to use random numbers, first determine the table to read the numbers, from left to right, the second assumption is to consider numbers for different groups, even numbers for the intervention group and odd numbers for Control group, Blinding description: Patients are divided into two groups A and B and the data analyzer is not aware of the treatment received by each group. Blinding is used to reduce the error rate. In this study, double-masked blinding is used in which both patients and evaluators of patient-related data are unaware of the exposure received. In these studies, the groups are identified by a code A and B, which is placed in an envelope, and elsewhere, it is specified that this group number is an intervention or a control. 2-3 Seborrheic keratosis. Intervention 1: Intervention group: Patients in the intervention group will receive topical hydrogen peroxide solution (40% by volume). The solution will be applied to the lesion so that it covers the entire surface of the lesion and then held for 20 seconds with rotational movements and pressure on the lesion. This operation is performed for all 4 lesions and the drug will be applied in each session for a total of 80 seconds. This cycle will be repeated 4 times in each session, which will be a total of 320 seconds. Patients will be monitored for pharmacological and dermatological side effects for at least 20 minutes after application of the solution. The effects of treatment, efficacy and safety of medication will be evaluated and in the next 8 weeks visit, patients will be evaluated only for the effects of treatment, efficacy and safety of medication and will not receive intervention. Intervention 2: Control group: Cryotherapy for the control group performed at the first visit, 3 weeks later and 6 weeks later And each time patients will be evaluated for the effects of treatment, efficacy and safety of medication and at the visit 8 weeks later Patients will only be evaluated for the effects of treatment, efficacy and safety of medication and will not receive intervention. Yes - There is a plan to make this available What will be shared: study data is categorized and coded with no identifiable individuals. When: access to study data after publication of the results is available in the journal To whom: anyone interested in using the data can access the study data. Conditions: study data can be used for comparison with other results. Where to obtain: refer to the study’s scientific or public accountability person for data. How to obtain: the request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Armaghan Gharehaghajizare
Azadi street, Sina hospital
Tabriz Iran (Islamic Republic of) 5138665789 +98 41 3549 8236 Ghareaghajia@tbmed.ac.ir Tabriz University of Medical Sciences scientific Armaghan Ghareh aghaji zare
Azadi street, Sina hospital
Tabriz Iran (Islamic Republic of) 5138665789 +98 41 3549 8236 Ghareaghajia@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Patient with definite diagnosis of seborrheic keratosis according to diagnostic criteria (Existence of at least one separate lesion in the trunk or limbs with a depth of 0 to 2 mm and length and width of 5 to 15 mm) Existence of at least 4 lesions of seborrheic keratosis in the individual Satisfaction to participate in the study 18 years no limit Both Presence of the lesion at the site of hair growth (so that the medicine does not reach the lesion well) Presence of a lesion on the eyelid Lesions at a distance of 5 mm from the eye L82 Seborrheic keratosis Treatment - Drugs Treatment - Devices Intervention group: Patients in the intervention group will receive topical hydrogen peroxide solution (40% by volume). The solution will be applied to the lesion so that it covers the entire surface of the lesion and then held for 20 seconds with rotational movements and pressure on the lesion. This operation is performed for all 4 lesions and the drug will be applied in each session for a total of 80 seconds. This cycle will be repeated 4 times in each session, which will be a total of 320 seconds. Patients will be monitored for pharmacological and dermatological side effects for at least 20 minutes after application of the solution. The effects of treatment, efficacy and safety of medication will be evaluated and in the next 8 weeks visit, patients will be evaluated only for the effects of treatment, efficacy and safety of medication and will not receive intervention. Control group: Cryotherapy for the control group performed at the first visit, 3 weeks later and 6 weeks later And each time patients will be evaluated for the effects of treatment, efficacy and safety of medication and at the visit 8 weeks later Patients will only be evaluated for the effects of treatment, efficacy and safety of medication and will not receive intervention The effectiveness of the treatment will be assessed by the Physician's Lesion Assessment Scale (PLA). The scoring of this scale is 4 numbers (0 = no lesion; 1 = almost no lesion; = Lesions with a depth of more than 1 mm) Patients will be evaluated by this scale at the time of the first visit, 3 weeks later, 6 weeks later and 8 weeks after receiving the treatment. will be. Timepoint: Physician’s lesion assesment scale measurement at the time of the first visit, 3 weeks later, 6 weeks later and 8 weeks after receiving treatment. Method of measurement: Physician’s lesion assesment scale score. Tabriz University of Medical Sciences Approved 2020-12-28 Ethics Committee of Tabriz University of Medical Sciences No. 3, 3rd Floor, East Avang Alley, Parvin Etesami St., Fatemi St., Tehran Tabriz East Azarbaijan Iran (Islamic Republic of)