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IRCT20170818035762N5 IRCT 2023-03-22 Mazandaran University of Medical Sciences Effect of Fractional CO2 laser in treatment of vitiligo Evaluation of using fractional CO2 laser combined with narrow-band ultraviolet B phototherapy vs NB-UVB monotherapy for non-segmental vitiligo 2022-12-06 anticipated 30 Complete https://irct.ir/trial/66969 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, two types of treatment are applied to patients. The first treatment includes the combination of phototherapy and laser and the second treatment is phototherapy alone. The first step is to randomize on which side of the patient's body phototherapy and laser will be performed together. First, a number is considered for each patient. From 1 to 15. Then the patients are divided into two groups, even and odd, by throwing a dice. In the next step, they are placed on the basis that, for example, those whose number is even will receive phototherapy treatment on the right side of the body. In this way, the combined laser and phototherapy treatment is performed on the right side of people with odd numbers, Blinding description: To eliminate the interfering effect of the doctor's level of experience and literacy, the treatment phase is performed only by the student and the evaluation phase is performed by the dermatologist. Before the treatment, each patient is photographed from both sides of the body with a camera, from a certain distance, and a certain intensity of the camera light, in a certain and fixed place on each side of the body by the student. Therefore, each patient has one photo for the left side and one photo for the right side before the treatment. After a certain period of treatment for all patients, the patient's evaluation will be done by the doctor. But before the doctor's evaluation, the photo will be taken again with the same conditions mentioned by the student. In fact, there will be 2 pieces of photos for each patient from each side of the body. One picture before the treatment and one picture after the treatment. Therefore, the doctor will not know which side of a patient received phototherapy alone or the combined treatment and only evaluate the repigmentation and reports the changes of two photos. N/A Non segmental vitiligo. Intervention 1: The intervention group will include one side of the body of all patients, which will be randomly selected. The selected side will be treated with UVB phototherapy combined with a fractional CO2 laser (for example, if the left side of the patient is selected as the intervention, the right side of that body will be considered control).The selected side as the intervention will be treated with UVB phototherapy for three months. During three months, patients will be subjected to phototherapy three times a week at least one day after the previous time with NB fluorescent tube (DAAVLIN company) with a spectrum of 310-315 nm and a maximum wavelength of 311 nm in a Waldmann UV-100. The initial dose of phototherapy will be 240 J/cm2 and each session will increase by 20% to achieve the minimum erythema dose.In addition to three months of UVB phototherapy on intervention sides, three sessions of fractional CO2 laser therapy on the first phototherapy session of each month will be administrated. Fractional CO2 laser (LUTRUNIC/surgical co2 laser (RF type) (model name: eco2 plus class 4)), with energy settings of 10 mJ/cm2 at a penetration depth of 10600 mm, 25% density. Antiviral pretreatment (valacyclovir 500 mg twice a day for 5 days) was prescribed for the patients and in the first 5 days after the laser session, the patients were asked to avoid using hot water in the treated area. Intervention 2: Control group: The control group will include one side of the body of all patients, which will be randomly selected. The selected side as control will be treated with phototherapy alone for three months. During three months, patients will be subjected to phototherapy three times a week at least one day after the previous times with NB fluorescent tube (DAAVLIN company) with a spectrum of 310-315 nm and a maximum wavelength of 311 nm in a Waldmann UV-100. The initial dose of phototherapy will be 240 J/cm2 and each session will increase by 20% to achieve the minimum erythema dose. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to the main outcome or similar, can be shared When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions can check the data, perform the statistical analysis they want to match, compare this study with other similar studies, and share the results if necessary. Where to obtain: Email to:A.kazeminejad@mazums.ac.ir How to obtain: After communicating by email, data and results will be available if conditions are met Comments:
public Dr.Armaghan Kazeminejad
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4414733971 +98 11 3304 4001 A.kazeminejad@mazums.ac.ir Mazandaran University of Medical Sciences scientific Armaghan Kazeminejad
Headquarters of Mazandaran University of Medical Sciences. At the beginning of Valiasr Highway.Sari
Sari Iran (Islamic Republic of) 4414733971 +98 11 3304 4001 A.kazeminejad@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Be over 18 years old suffering from non-segmented vitiligo It has generalized waste (at least 10%). Three months have passed since their last treatment The lesion has been stable during the last year 18 years no limit Both Pregnant or breastfeeding Have a history of severe sensitivity to light Have eye cataracts or skin cancer Have a history of keloid scars L80 Vitiligo Treatment - Other Treatment - Other The intervention group will include one side of the body of all patients, which will be randomly selected. The selected side will be treated with UVB phototherapy combined with a fractional CO2 laser (for example, if the left side of the patient is selected as the intervention, the right side of that body will be considered control).The selected side as the intervention will be treated with UVB phototherapy for three months. During three months, patients will be subjected to phototherapy three times a week at least one day after the previous time with NB fluorescent tube (DAAVLIN company) with a spectrum of 310-315 nm and a maximum wavelength of 311 nm in a Waldmann UV-100. The initial dose of phototherapy will be 240 J/cm2 and each session will increase by 20% to achieve the minimum erythema dose.In addition to three months of UVB phototherapy on intervention sides, three sessions of fractional CO2 laser therapy on the first phototherapy session of each month will be administrated. Fractional CO2 laser (LUTRUNIC/surgical co2 laser (RF type) (model name: eco2 plus class 4)), with energy settings of 10 mJ/cm2 at a penetration depth of 10600 mm, 25% density. Antiviral pretreatment (valacyclovir 500 mg twice a day for 5 days) was prescribed for the patients and in the first 5 days after the laser session, the patients were asked to avoid using hot water in the treated area. Control group: The control group will include one side of the body of all patients, which will be randomly selected. The selected side as control will be treated with phototherapy alone for three months. During three months, patients will be subjected to phototherapy three times a week at least one day after the previous times with NB fluorescent tube (DAAVLIN company) with a spectrum of 310-315 nm and a maximum wavelength of 311 nm in a Waldmann UV-100. The initial dose of phototherapy will be 240 J/cm2 and each session will increase by 20% to achieve the minimum erythema dose. Repigmentation score. Timepoint: Before the intervention, and 1 month after the end of the intervention. Method of measurement: Investigating the percentage of repigmentation of vitiligenous lesions. Mazandaran University of Medical Sciences Approved 2022-11-30 Ethics committee of mazandaran University of Medical Sciences Central Headquarters of Mazandaran University of Medical Sciences,at the beginning of Valiasr Highway,Joibar Three Ways,Imam Square, Sari Sari Mazandaran Iran (Islamic Republic of)