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IRCT20220620055230N1 IRCT 2022-09-26 Tehran University of Medical Sciences Investigation of the effect of Masport on Excessive Underarm Sweating A Double blind, Randomized, Comparative study of the Efficacy and Safety of Botulinum Toxin type A Masport with commercial brand Dysport in the treatment of Primary Axillary Hyperhidrosis 2022-09-06 anticipated 15 Complete https://irct.ir/trial/64439 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The Randomization process using lottery will be done for patients 1 to 15 by order of referral in such a way that a lot will be drown from the lots that have the name of drug and corresponding Axilla (for example Masport- Right), Blinding description: In this study each participant will receive both control and test drug in parallel in two axilla (one drug in each axilla). The botulinum toxin vials of test and control group will be covered in a way that neither the doctor nor the patient will know the brand of drugs used in each axilla. The evaluation of treatment effectiveness will be done in 2 ways. Once with sweating measurement by the nurse who is not aware of the botulinum toxin brand used in each axilla and once according to the patient assessment regarding the amount of sweating, which is mentioned earlier, the patient has no knowledge of the botulinum toxin brand used in each axilla. Only the researcher who designed the study knows the type of botulinum toxin used in each axilla in each patient. 3 Primary Axillary Hyperhydrosis. Intervention 1: Intervention group:All 15 participants in this study will be injected with 165 IU botulinum toxin type A Masport (each vial contains 500 IU of botulinum toxin type A that will be diluted with 3 cc normal saline) which is produced by Masoon Darou pharmaceutical company, Iran in one of their two axillae. This injection will be done once and participants will be evaluated during a period of 6 months after injection. Intervention 2: Control group: All 15 participants in this study will be injected with 165 units botulinum toxin type A Dysport (each vial contains 500 units of botulinum toxin type A that will be diluted with 3 cc normal saline) manufactured by Ipsen Company, England in one of their two axillae. This injection will be done once and participants will be evaluated during a period of 6 months after injection. Yes - There is a plan to make this available What will be shared: Documentation of randomization process, Documentation of the sweating intensity before and after treatment based on qualitative questionnaire of sweating interference with daily activities, Documentation of the sweating intensity before and after treatment based on quantitatively Gravimetry questionnaire can be requested after completing the study. The documentation related to the type of statistical analysis method and the corresponding codes of each of the two types of botulinum toxin can be requested after completing the study. The informed consent form, which will be available to the participants for signature on day zero, can be requested after completing the study. All data is potentially shareable after de-identifying individuals. When: Access to the data will be after the results are published. To whom: the data will be accessible to all researchers. Conditions: There is no problem using the data in other studies as long as the source is mentioned. Where to obtain: Kamand Hedayat kamandhedayat@yahoo.com Pasteur street, No 69, Pasteur Institute of Iran. tel: 66953311 -0098-21 fax: 66465132 -0098-21 How to obtain: The researcher requests access to the data preferably through email and it will be send to him within a maximum of 10 days. Comments:
public kamand Hedayat
No. 69, Pasteur Ave
Tehran Iran (Islamic Republic of) 1316943551 +98 21 6695 3311 kamandhedayat@yahoo.com Pasture Institute of Iran scientific Kamand Hedayat
No. 69, Pasteur Ave
Tehran Iran (Islamic Republic of) 1316943551 +98 21 6695 3311 kamandhedayat@yahoo.com Pasture Institute of Iran Iran (Islamic Republic of) Adults aged between 18 to 65 years who have a sweating rate of 50 mg per minute or higher. 18 years 65 years Both secondary Hyperhidrosis due to systemic problems. Pregnancy Lactation people who have taken Aminoglycosides in the last three weeks. people who have had botulinum toxin injection in the past year. people with Neuromuscellar diseases L74.510 Primary focal hyperhidrosis, axilla Treatment - Drugs Treatment - Drugs Intervention group:All 15 participants in this study will be injected with 165 IU botulinum toxin type A Masport (each vial contains 500 IU of botulinum toxin type A that will be diluted with 3 cc normal saline) which is produced by Masoon Darou pharmaceutical company, Iran in one of their two axillae. This injection will be done once and participants will be evaluated during a period of 6 months after injection. Control group: All 15 participants in this study will be injected with 165 units botulinum toxin type A Dysport (each vial contains 500 units of botulinum toxin type A that will be diluted with 3 cc normal saline) manufactured by Ipsen Company, England in one of their two axillae. This injection will be done once and participants will be evaluated during a period of 6 months after injection. The score of sweating rate in the questionnaire of "Hyperhidrosis disease severity scale" by patients. Timepoint: scoring of the amount of sweating will be done on day 0 (before the stat of the study), 14, 90 and 180 days after botulinum toxin injection. Method of measurement: The questionnaire "Hyperhidrosis disease severity scale". Sweating rate based on Gravimetry test. Timepoint: measurement of the sweating will be done on day 0 (before the stat of the study), 14, 90 and 180 days after botulinum toxin injection. Method of measurement: Using a digital scale. Occurrence of the side effects, The time of onset and duration of the complication. Timepoint: Patients will be able to report occurrence of the side effects throughout the study, but they will be asked specifically on 14th, 90th and 180th after Botulinum Toxin injection. Method of measurement: Statements of patients. Masoon Darou Pharmaceutical Company Approved 2022-02-12 Ethics committee of Tehran University of Medical Sciences No. 69, Pasteur Ave Tehran Tehran Iran (Islamic Republic of)