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IRCT20220110053685N1 IRCT 2022-12-26 Tehran University of Medical Sciences The effect of timolol eye drops on rosacea Therapeutic effect of 0.5% thymolol eye drops on rosacea lesions of the face in comparison with placebo 2022-01-15 anticipated 44 Complete https://irct.ir/trial/61213 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign the samples to two experimental groups, the random block method (block randomization) has been used, considering blocks of 4, 6, and 8. An online software at https://www.sealedenvelope.com/simple-randomiser/v1/lists was used to generate a sequence of random numbers. In order to reproduce the randomization sequence, seed equal to 36821706636683 was used, Blinding description: The container containing the drug and placebo will be unlabeled, and all the containers will be similar and indistinguishable, and another person will give the desired drug to the patients based on the block order. The doctor, the patient, the person assessing the outcome and the person analyzing will not know the content of the drug. 3 Condition 1: rosacea. Condition 2: rosacea. Intervention 1: Intervention group: Patients in the intervention group are given half percent timolol maleate eye drops from Sina Daru, and two drops of the solution are used on each side of the face once every night before going to bed. Then, patients will be evaluated for erythema, flushing, and side effects at the beginning of treatment and before treatment, one and two months later, and one month after stopping treatment. Intervention 2: Control group: patients are given a medicinal bottle containing distilled water and two drops of the solution are used on each side of the face once every night before going to bed. Then, patients will be evaluated for erythema, flushing, and side effects at the beginning of treatment and before treatment, one and two months later, and one month after stopping treatment. Yes - There is a plan to make this available What will be shared: all information o patients can be shared without mentioning the name When: From 6 months after the end of the study until forever. To whom: Researchers and pharmaceutical companies Conditions: For scientific studies and use in therapy Where to obtain: tehran univercity of medical sciences How to obtain: By sending an email to Tehran University of Medical Sciences and after reviewing the action is done. Admin@irct.ir Comments:
public ali moradi
vahdate eslami st, razi hospital
tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 dralimoradi20@gmail.com Tehran University of Medical Sciences scientific ali moradi
vahdate eslami st, razi hospital
tehran Iran (Islamic Republic of) 1199663911 +98 21 5563 0553 dralimoradi20@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Ability to cooperate to refer at the appointed time. Ability to cooperate to necessary cooperation in taking the drug. consciously understanding the consent and accepting its provisions. agreeing not to breastfeed and pregnancy during the study and one month later in women of childbearing age. willingness not to take other drugs during the study. Have the criteria for diagnosing rosacea. 18 years 65 years Both Receive any research medication within 30 days prior to enrollment. history of allergy to beta-blocker, pregnancy or attempt to conceive or breastfeed. severe depression. history of hypotension or bradycardia, history of myocardial infarction or heart failure. history of arrhythmia, history of asthma or bronchospasm. Taking any rosacea stimulant such as calcium channel blocker during the study. taking alpha or beta blocker drugs. not cooperating in the correct use of the drug or visiting at the appointed time. specific exclusion criteria including taking oral or topical drugs such as antibiotics during 3 weeks before Study criteria for excluding diagnostic biopsy including lidocaine allergy or a history of hypertrophic or colloidal scarring. L71 T44.7X5 Rosacea Adverse effect of beta-adrenoreceptor antagonists Treatment - Drugs Treatment - Drugs Intervention group: Patients in the intervention group are given half percent timolol maleate eye drops from Sina Daru, and two drops of the solution are used on each side of the face once every night before going to bed. Then, patients will be evaluated for erythema, flushing, and side effects at the beginning of treatment and before treatment, one and two months later, and one month after stopping treatment. Control group: patients are given a medicinal bottle containing distilled water and two drops of the solution are used on each side of the face once every night before going to bed. Then, patients will be evaluated for erythema, flushing, and side effects at the beginning of treatment and before treatment, one and two months later, and one month after stopping treatment. Investigation of flushing based on Global Flushing Severity Score criteria. Timepoint: At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication. Method of measurement: It is scored by the patient based on the Global Flushing Severity Score between 0-10. Evaluation of erythema based on the Clinician Erythema Assessment Scale. Timepoint: At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication. Method of measurement: A number between 0 and 4 is given by the doctor based on the Clinician Erythema Assessment Scale. Evaluation of erythema based on Patient's self assessment criteria. Timepoint: At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication. Method of measurement: It is scored by the patient based on the Patient's self assessment criteria between 0-4. Evaluation of erythema based on the mx18 probe of the mexameter device. Timepoint: At the beginning of the study, one month later and two months after the start of the treatment, one month after stopping the medication. Method of measurement: mx18 probe of the mexameter device. Investigation of the side effects of 0.5% timolol maleate eye drops. Timepoint: At the beginning of the study, one month and two months after starting the treatment and one month after stopping the medication. Method of measurement: questionnaire. Erythema relapse investigation after discontinuation of treatment based on the Clinician Erythema Assessment Scale. Timepoint: A month later, stop taking the medicine. Method of measurement: Doctor evaluation based on Clinician Erythema Assessment Scale between 0-4. Tehran University of Medical Sciences Approved 2021-12-01 Ethics Committee in Research of Imam Khomeini Hospital Complex - Tehran University of Medical Scienc taleqani street tehran Tehran Iran (Islamic Republic of)