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IRCT20120215009014N283 IRCT 2019-05-29 Hamedan University of Medical Sciences Comparison of effect of NB-UVB with and without topical Latanoprost solution or placebo in Vitiligo Patients Comparison of effect of NB-UVB with and without topical Latanoprost solution or placebo in Vitiligo Patients: a triple-blind clinical trial study 2019-06-22 anticipated 30 Complete https://irct.ir/trial/39875 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the right and left sides of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the intervention group and the other side to the control group, Blinding description: The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Thus, the trial will be run as triple blind. 2 Vitiligo. Intervention 1: Intervention group: NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a Latanoprost solution 0.005% twice a day for three consecutive months. Intervention 2: Control group: NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a normal saline solution twice a day for three consecutive months. 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 It depends on the situations and the results of the study as well as approval of the financial supporting organization.
public Dr Hanieh Karimi
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3827 4184 haniehkarimi67@gmail.com Hamedan University of Medical Sciences scientific Dr. Pedram Alirezaei
Sina Hospital, Mirzadeh Eshghi Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3827 4184 prc@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 12 to 70 years Vitiligo lesions with at least one lesions on each sides Involving at least 20% of the body surface 12 years 70 years Both Malignant skin disease Failure of previous radiotherapy Pregnancy or breastfeeding Hepatic or renal disease Lupus Erythematosus Photosensitivity L80 Vitiligo Treatment - Drugs Placebo Intervention group: NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a Latanoprost solution 0.005% twice a day for three consecutive months Control group: NB-UVB radiation at a dose of 0.3 J/cm2 (wavelength from 311 to 313 nm) for a maximum of 3 minutes three times a week for three consecutive months with a normal saline solution twice a day for three consecutive months Improvement of Vitiligo lesions. Timepoint: 3 months after the intervention. Method of measurement: With physical examination. Hamedan University of Medical Sciences Approved 2018-05-18 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)