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IRCT20211010052723N2 IRCT 2022-07-01 Esfahan University of Medical Sciences Evaluation of the effect of different microbotox methods in the treatment of open pores Comparison of the effect of botulinum toxin A injection by microneedling with intradermal injection by syringe in the treatment of patients with open pores 2022-07-23 anticipated 35 Complete https://irct.ir/trial/64249 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: Dermoscopy and photography will be evaluated by two Non-performing dermatologists will be evaluated. 3 Dilated pores. Intervention 1: Intervention group:Using local anesthesia at the treatment site, which remains on the site for half an hour, then the site is washed with normal saline and sterilized using aseptic solution. Then botulinum toxin A (dyston )for use in patients is concentrated to 100 units in 2.5 ml with 9% normal saline, then in syringes of one cc with 30 gauge, so that each syringe contains 20 units of botulinum is prepared Then we treat one side of the face with 24-tooth microneedling to a depth of 3 to 3.5 mm until the pinpoint bleeding is continued.Then we use botulinum material on the spot so that 50 units of solution are used on one side of the face. Intervention 2: The second intervention group: On the other side of the face, we make one cc with the pre-prepared syringes at a distance of one centimeter inside each dermis so that a delicate protrusion is created and 50 units of the solution are used. Yes - There is a plan to make this available What will be shared: At the end of the study, study protocol, statistical analysis and clinical study report,the informed consent form, the codes used in the data analysis and the data dictionary can be shared with other researchers. When: Access period starts one month after the results are published To whom: Data will be available to researchers working in academic and scientific centers Conditions: Researchers can use the findings and data of this study in their research by submitting a document that proves their employment in scientific and academic centers. Where to obtain: Researchers can receive study data via sending an E-mail to researcher E-mail:Aabedini.ma@gmail.com phone number: 09128021807 Dr Mahya Abedini address: , Behdari lashgar Ave, Artesh Blv, Isfahan, Iran How to obtain: Researchers can send an email to the address to indicate the type of data they need, and after reviewing their request, the information will be sent to them via email. Comments:
public Mahya Abedini
No 58, Madanian Ave, Behdari lashgar St, Artesh Blvr
Isfahan Iran (Islamic Republic of) 8174755636 +98 31 3621 8308 Aabedini.ma@gmail.com Esfahan University of Medical Sciences scientific Farina iraji
Skin research center, sedigheh there hospital,khorram St, Jomhouri Sq
Isfahan Iran (Islamic Republic of) 9819181876 +98 31 3335 9090 Iraji@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patient consent to participate in the study Age over 25 years No history of allergic reaction to botulinum toxin 25 years 60 years Both Taking topical retinoids or oral isotretinoin in the last three months Laser or chemical peels during the last 6 months Myasthenia Gravis Pregnant and lactating women Treatment - Devices Treatment - Devices Intervention group:Using local anesthesia at the treatment site, which remains on the site for half an hour, then the site is washed with normal saline and sterilized using aseptic solution. Then botulinum toxin A (dyston )for use in patients is concentrated to 100 units in 2.5 ml with 9% normal saline, then in syringes of one cc with 30 gauge, so that each syringe contains 20 units of botulinum is prepared Then we treat one side of the face with 24-tooth microneedling to a depth of 3 to 3.5 mm until the pinpoint bleeding is continued.Then we use botulinum material on the spot so that 50 units of solution are used on one side of the face. The second intervention group: On the other side of the face, we make one cc with the pre-prepared syringes at a distance of one centimeter inside each dermis so that a delicate protrusion is created and 50 units of the solution are used. Dermoscopic changes. Timepoint: Before and one month after. Method of measurement: Dermoscopy (number of pores and their size in a specific area) by examining shallow holes, holes filled with keratotic plugs and yellow spots. The Quartile improvement scale. Timepoint: One month after doing. Method of measurement: Photographs will be taken before and one month after treatment and the pore size improvement will be evaluated by two dermatologists who are blind to the study with the Quartile improvement scale (0-4 scale) as follows (11). ) 0 = No improvement1 = Minor / mild improvement (1% -25%) 2 = Moderate improvement (26% -50%) 3 = Marked improvement (51% -75%) 4 = Very significant improvement (76% -100% ). Likert satisfaction. Timepoint: One month after work. Method of measurement: Also, one month after treatment, the Likert satisfaction criterion (1-5 scale) will be used to assess patient satisfaction. (11)1 = Very dissatisfied2 = Dissatisfied3 = Neither satisfied nor dissatisfied4 = Satisfied5 = Very satisfied. Esfahan University of Medical Sciences Approved 2022-06-01 Ethics Committee of Isfahan University of Medical Sciences No. 58, Shania Madanian Ave, Behdari Lashgar Street, A rtesh Blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)