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IRCT20150825023753N21 IRCT 2023-11-15 Shiraz University of Medical Sciences The effect of Vitilexine Cream Givrelle in comparison with placebo in the treatment of patients with vitiligo undergoing phototherapy Evaluation of the effect of Vitilexine Cream Givrelle in comparison with placebo in the treatment of patients with vitiligo undergoing phototherapy 2023-11-21 anticipated 35 Complete https://irct.ir/trial/60657 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: By using Random Allocation Software, consecutive permutation blocks with the size of 4 lesions in each block are made and the lesions are divided into two groups A (right side) and B (left side). Dark-colored envelopes will be used to hide random allocation, Blinding description: To blind the researcher, the drugs are named A (Vitilexine Cream Givrelle) and B (placebo cream). The drug and placebo are similar in terms of shape, color, and consistency. The patient is also not aware of the type of medicine assigned to him. Also, the groups are coded as A and B and delivered to the statistical analyzer. 2-3 Vitiligo. Intervention 1: One of the lesions located on one side of the body will receive Vitilexine Cream Givrelle twice a day for three months. Also, patients will be treated with narrowband ultraviolet B (nb-UVB) three times a week. The initial dose of radiation will be determined between 0.5 and 1 J/cm2 based on the lesions and the skin type of the patients, and then the radiation dose will be increased based on whether or not stable erythema occurs (every week by 0.1 J/cm2). In cases of long-term irritation or erythema, the radiation dose is reduced by 0.1 J/cm2, and when the irritation is removed, the dose will increase again by 0.1 J/cm2. In each session before the start of phototherapy, the related complications are examined, and phototherapy continues for three months or until the lesions are removed. Each patient is examined and followed up once at the beginning of the treatment and then every one and a half months. At the end of a month and a half and three months later, the lesions are photographed again. Intervention 2: Control group: One of the lesions located on one side of the body will receive placebo twice a day for three months. Also, patients will be treated with narrowband ultraviolet B (nb-UVB) three times a week. The initial dose of radiation will be determined between 0.5 and 1 J/cm2 based on the lesions and the skin type of the patients, and then the radiation dose will be increased based on whether or not stable erythema occurs (every week by 0.1 J/cm2). In cases of long-term irritation or erythema, the radiation dose is reduced by 0.1 J/cm2, and when the irritation is removed, the dose will increase again by 0.1 J/cm2. In each session before the start of phototherapy, the related complications are examined, and phototherapy continues for three months or until the lesions are removed. Each patient is examined and followed up once at the beginning of the treatment and then every one and a half months. At the end of a month and a half and three months later, the lesions are photographed again. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: One year later To whom: Researchers Conditions: After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews. Where to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. How to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. Comments: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system.
public Dr. Samaneh Yekran
Zand Ave, Shahid Faghihi Hospital,
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 s_yekran@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Nasrin Saki
Zand Ave, Shahid Faghihi Hospital,
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 nasrinsa85@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) The patient's age is over 18 years The presence of at least 2 vitiligo corneal lesions in the upper, lower limbs, face or trunk that are similar in size and color The disease is under control (non-progressive). Involvement of at least 10% of the body surface Patients willing to participate in the study 18 years no limit Both Use of topical medications in the last month Having an immune deficiency Any contraindication for phototherapy such as a history of skin cancer Pregnant and lactating women L80 Vitiligo Treatment - Drugs Placebo One of the lesions located on one side of the body will receive Vitilexine Cream Givrelle twice a day for three months. Also, patients will be treated with narrowband ultraviolet B (nb-UVB) three times a week. The initial dose of radiation will be determined between 0.5 and 1 J/cm2 based on the lesions and the skin type of the patients, and then the radiation dose will be increased based on whether or not stable erythema occurs (every week by 0.1 J/cm2). In cases of long-term irritation or erythema, the radiation dose is reduced by 0.1 J/cm2, and when the irritation is removed, the dose will increase again by 0.1 J/cm2. In each session before the start of phototherapy, the related complications are examined, and phototherapy continues for three months or until the lesions are removed. Each patient is examined and followed up once at the beginning of the treatment and then every one and a half months. At the end of a month and a half and three months later, the lesions are photographed again. Control group: One of the lesions located on one side of the body will receive placebo twice a day for three months. Also, patients will be treated with narrowband ultraviolet B (nb-UVB) three times a week. The initial dose of radiation will be determined between 0.5 and 1 J/cm2 based on the lesions and the skin type of the patients, and then the radiation dose will be increased based on whether or not stable erythema occurs (every week by 0.1 J/cm2). In cases of long-term irritation or erythema, the radiation dose is reduced by 0.1 J/cm2, and when the irritation is removed, the dose will increase again by 0.1 J/cm2. In each session before the start of phototherapy, the related complications are examined, and phototherapy continues for three months or until the lesions are removed. Each patient is examined and followed up once at the beginning of the treatment and then every one and a half months. At the end of a month and a half and three months later, the lesions are photographed again. Severity of vitiligo. Timepoint: Before the intervention, 6 weeks later, 12 weeks later. Method of measurement: Vitiligo Area Scoring Index (VASI). Shiraz University of Medical Sciences Approved 2023-08-12 Ethics committee of Medical School of Shiraz University of Medical Sciences Medical School of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)