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IRCT20220101053588N1 IRCT 2022-01-24 Skin Research Center Of Shahid Beheshti Universiy Of Medical Sciences Comparison between microneedling plus topical tranexamic acid and microneedling in patients with macular amyloidosis Comparison between microneedling plus topical tranexamic acid and microneedling in patients with macular amyloidosis 2022-01-12 anticipated 22 Complete https://irct.ir/trial/61091 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: One of the randomization methods is using the RANDBETWEEN function in Excel. This function allows us to generate random numbers. To generate a random number in this study with a sample size of 22, between the two numbers 1 and 0, the function = (0,1) Randbetween is used. This function creates a column of random numbers from 0 to 1. The rand () function sets the numbers with equal probability in this selection interval. The chance of selecting any number in this interval is equal to the other numbers. This means that the treatment on the left or right side of the back or arms of each person is assigned to enter one of two treatments (doing treatment / not doing treatment). These data are 22 people that are randomly assigned to the numbers 0 and 1. In total, people with the number 1 receive treatment on the right side and people with the number 0 receive treatment on the left side of their body. No Right=1,left=0 1 1 2 0 3 1 4 0 5 0 6 1 7 0 8 0 9 1 10 0 11 1 12 1 13 0 14 0 15 1 16 1 17 1 18 0 19 0 20 1 21 1 22 0, Blinding description: The method of one-sided blinding in this study will be that the statistical analyst is unaware of the eطposure recثهved by patients. 3 Macular Amyloidosis. Intervention 1: Intervention group: First, all patients who have the criteria to enter the Survey, informed i consent to participate in the study is obtaibed. Prior to treatment, any contamination is removed from the skin with saline solution, and an anesthetic gel (lidocaine 2.5% and prilocaine 2.5%) is used and left on the skin for 30 minutes. The anesthetic gel is then removed from the skin and the site is disinfected with alcohol. One half of the lesion was randomly (using a random number table) treated with microneedling (With 36 needles cartridge and a depth of 0.5 to 1 mm until blood dew was observed) and 5 cc of tranexamic acid solution (500mg / 5cc). The other half is treated with microneedling (With 36 needles cartridge and with a depth of 0.5 to 1 mm until blood clot is observed) and the patient stops using mometasone for 24 hours after each treatment session and The patient avoids washing the areas and after 24 hours,. Patients apply a thin layer of mometasone to the lesions once daily. It is recommended not to use other topical medications during treatment. Four sessions of treatment at two-week intervals are performed on each patient. Patients are examined and photographed with Fotofinder in the first session (baseline time) and two weeks after the end of treatment. Side effects are measured in the second session of treatment and patients are advised in case of any complications at any time to refer to make decisions or the interventions. Intervention 2: Control group: Other side of the patient's body which is not treated with tranexamic acid. Other interventions are the same as case group. Yes - There is a plan to make this available What will be shared: All information except the patient name When: One year after publishing the article To whom: Researchers Conditions: All information except the patient name is available. Where to obtain: The researcher of this study, Dr Mehdi Gheisari How to obtain: sending Email to the researcher: mgheisari@sbmu.ac.ir Comments:
public Mehdi Gheisari
Shohadaye Tajrish Hospital. 1989934148.Shahrdari St, Tehran Province, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 mgheisari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Mehdi Gheisari
Shohadaye Tajrish Hospital. 1989934148.Shahrdari St, Tehran Province, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 mgheisari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18-60 Confirming the diagnosis of macular amyloidosis by a dermatologist bilateral macular amyloidosis on trunk and extremities Patients with skin type 2_4 Fitzpatrick Filling out the informed consent form 18 years 60 years Both Pregnancy and lactation Past history of keloid formation Presence of active acne on site of macular amyloidosis Other skin disorders Hypersensitivity to lidocaine Application of other topical medications in the past month e85.8 Other amyloidosis Treatment - Drugs Treatment - Drugs Intervention group: First, all patients who have the criteria to enter the Survey, informed i consent to participate in the study is obtaibed. Prior to treatment, any contamination is removed from the skin with saline solution, and an anesthetic gel (lidocaine 2.5% and prilocaine 2.5%) is used and left on the skin for 30 minutes. The anesthetic gel is then removed from the skin and the site is disinfected with alcohol. One half of the lesion was randomly (using a random number table) treated with microneedling (With 36 needles cartridge and a depth of 0.5 to 1 mm until blood dew was observed) and 5 cc of tranexamic acid solution (500mg / 5cc). The other half is treated with microneedling (With 36 needles cartridge and with a depth of 0.5 to 1 mm until blood clot is observed) and the patient stops using mometasone for 24 hours after each treatment session and The patient avoids washing the areas and after 24 hours,. Patients apply a thin layer of mometasone to the lesions once daily. It is recommended not to use other topical medications during treatment. Four sessions of treatment at two-week intervals are performed on each patient. Patients are examined and photographed with Fotofinder in the first session (baseline time) and two weeks after the end of treatment. Side effects are measured in the second session of treatment and patients are advised in case of any complications at any time to refer to make decisions or the interventions. Control group: Other side of the patient's body which is not treated with tranexamic acid. Other interventions are the same as case group Clinical improvement of pigmentation. Timepoint: first session and two weeks after final session. Method of measurement: comparison of photos by 2 dermatologist and fotofinder device. Pigmentation pattern. Timepoint: first session and two weeks after final session. Method of measurement: checking for rippling. Patient satisfaction. Timepoint: two weeks after final session. Method of measurement: asking the patient. Side effects. Timepoint: Since 2weeks after starting of the treatment, till 2 weeks after the last session. Method of measurement: Asking the patient, examination by dermatologist. Skin Research Center Of Shahid Beheshti Universiy Of Medical Sciences Approved 2021-08-07 Research Ethics Committees of Skin Research Center- Shahid Beheshti University of Medical Sciences The SBMU SRC (Skin Research Center), Shohada-E- Tajrish Educational Hospital, Qods Sq. , Tehran, Iran Tehran Tehran Iran (Islamic Republic of)