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IRCT20200811048363N1 IRCT 2021-03-04 Esfahan University of Medical Sciences Comparative study of 1064nm Q-switched ND:YAG laser and Er:YAG2940nm laser in treatment of macular amyloidosis Comparative study of 1064nm Q-switched ND:YAG laser and Er:YAG2940nm laser in treatment of macular amyloidosis 2021-03-05 anticipated 39 Complete https://irct.ir/trial/53094 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to the fact that in our study both types of interventions will performed on one person (split lesion method), randomization only applies to the side of the patient's lesion. Our method for randomization is based on even and odd calendar days, so patients referred on the even days , right side of the lesions will considred area- A (Q-switched laser 1064nm) and the left side of the lesion will considered as area- B (Erbium laser 2940). For the patients referred on the odd dates allocation of the intervention area will be the opposite, Blinding description: Due to the fact that the type of laser intervention is high-power lasers, in order to protect the patient, he/she should use lead protective eyewear, during the process, so she/he will be unaware of the laser type; results will be compared by befor and after (intervention) photographs, by a neutral specialist who is unaware of the type and location of various treatments. N/A macular amyloidosis. Intervention 1: Intervention group: In each patient, the lesion will be randomly divided into 2 zones A and B (two squares of equal size). Zone A under 4 treatment sessions with 4-week intervals of Nd: YAG 1064nm Q-switched laser (device: HeliosIII) with fluence parameters 14 J/cm2 , spot size 3mm, energy 1000j . Also for all patients, Kligman combination (including: 0.05% tretinoin, 5% hydroquinone and 0.05% clobetasol in ethanol-based ) will be prescribed for daily use on the lesions at home. Intervention 2: Intervention group: In each patient, the lesion will be randomly divided into 2 zones A and B (two squares of equal size) and zone B will under 4 treatment sessions with 4 weeks intervals of laser Er: YAG2940 (Lotus II device, Laseroptek) with parameters: spot size 10mm / energy: 1500j and fe: 3Hz and immediately take clobetasol ointment. Also for all patients, Kligman combination (including: 0.05% tretinoin, 5% hydroquinone and 0.05% clobetasol in ethanol-based ) will be prescribed for daily use on the lesions at home. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Due to not starting the study and intervention, this decision is postponed until the end of the study and consultation with the rest of the research team.
public Maral Yazdanpanah
No.32, Baghe-Negar Ave., Chahar-Bagh-Bala St
Isfahan Iran (Islamic Republic of) 8163675791 +98 31 3667 1163 marlyyazdan@yahoo.com Esfahan University of Medical Sciences scientific Maral Yazdanpanah
No.32, Baghe-Negar Ave.,Chahar-bagh_Bala St
Isfahan Iran (Islamic Republic of) 8163675791 0098313671163 marlyyazdan@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with macular amyloidosis clinical symptoms Patients with at least 5 to 10 cm2 macular amyloidosis skin lesion on the trunk or limbs At least 6 months have passed since the onset of skin lesion 18 years 60 years Both Pregnancy, breastfeeding or deciding to get pregnant in the next 2 months Personal history of hypertrophic scar or keloid formation Personal history of melanoma or other skin cancers History of systemic retinoid therapy during last 6 months History of any systemic treatment during the last 3 months for macular amyloidosis history of any topical treatment during the last month for macular amyloidosis E85.4 Organ-limited amyloidosis Treatment - Other Treatment - Other Intervention group: In each patient, the lesion will be randomly divided into 2 zones A and B (two squares of equal size). Zone A under 4 treatment sessions with 4-week intervals of Nd: YAG 1064nm Q-switched laser (device: HeliosIII) with fluence parameters 14 J/cm2 , spot size 3mm, energy 1000j . Also for all patients, Kligman combination (including: 0.05% tretinoin, 5% hydroquinone and 0.05% clobetasol in ethanol-based ) will be prescribed for daily use on the lesions at home. Intervention group: In each patient, the lesion will be randomly divided into 2 zones A and B (two squares of equal size) and zone B will under 4 treatment sessions with 4 weeks intervals of laser Er: YAG2940 (Lotus II device, Laseroptek) with parameters: spot size 10mm / energy: 1500j and fe: 3Hz and immediately take clobetasol ointment. Also for all patients, Kligman combination (including: 0.05% tretinoin, 5% hydroquinone and 0.05% clobetasol in ethanol-based ) will be prescribed for daily use on the lesions at home. Intensity changes of pigmentation. Timepoint: Before the intervention (0) ; 4 weeks after the last session of intervention. Method of measurement: photography with a single camera. Intensity changes of pigmentation. Timepoint: Before the intervention (0) ; 4 weeks after the last session of intervention. Method of measurement: Questionnaire with Visual Analogue Scale. Intensity changes of itching. Timepoint: Before the intervention (0) ; 4 weeks after the last session of intervention. Method of measurement: Questionnaire with Visual Analogue Scale. Esfahan University of Medical Sciences Approved 2019-07-09 Iran National Commitee for Ethnics in Biomedical Research No32, Baghe-Negar Ave., Chahar-Bagh-bala St., Isfahan Isfahan Isfehan Iran (Islamic Republic of)