]>
IRCT20140414017271N4 IRCT 2018-02-04 Mashhad University of Medical Sciences Evaluation the effect of Laser on treatment of macular amyloidosis Evaluation the effect of Fractional Erbium glass 1540 Laser on treatment of macular amyloidosis 2016-07-25 anticipated 15 Complete https://irct.ir/trial/15934 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Then, patients’ lesions are divided to 2 areas by random. One side is then treated with Fractional Erbium glass 1540 Laser (area A) and the other side, as control group, receives no treatment (area B). 3 macular amyloidosis. Intervention 1: intervention group: one part of lesion receives Fractional non-ablative erbium laser for 3 sessions and its energy ranges from 8 to 15 Mj/MB2. Intervention 2: control group: one part of lesion receives no treatment. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Dr. Rozita Delghandi
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2020 delghandir931@mums.ac.ir Mashhad University of Medical Sciences scientific Dr Yalda Nahidi
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2020 nahidiy@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Clinically confirmed macular amyloidosis macular amyloidosis lesions should be on upper back area o current skin diseases like active dermatitis, active acne, hypertrophic scars or keloids patients with Fitzpatrick skin types 2 to 4 written informed consent from patients for participation in the study and digital imaging from lesions no use of Isotretinoin during the last 3 month having no heart pacemaker no record of sensitivity to lidocaine no limit no limit Female unreal expectations from treatment results macular amyloidosis lesions not being on upper back areas intolerance against laser treatment pregnancy during treatment unwillingness of patient to continue participating in the study or digital imaging from lesions Coagulopathy Patients who were under topical treatment one month before study existence of hypertrophic scars or keloids Treatment with systemic retinoid during the last 6 month other dermatologic diseases like skin infections and active lesions in the treatment area L99.0 Amyloidosis of skin Treatment - Other Treatment - Other intervention group: one part of lesion receives Fractional non-ablative erbium laser for 3 sessions and its energy ranges from 8 to 15 Mj/MB2. control group: one part of lesion receives no treatment. Lesion pigmentation. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (1:low, 2:medium, 3:noticeable). Rate of rippling. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (0:without rippling, 1:with rippling). Intensity of lesion. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (0:without Lichenification, 1:with Lichenification). Itching. Timepoint: During therapy, after each laser session and three month after last session. Method of measurement: Based on a grading system (0:without itching, 1:with itching). Mashhad University of Medical Sciences Approved 2016-06-08 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi),Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)