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IRCT20150825023753N11 IRCT 2019-03-30 Shiraz University of Medical Sciences The effect of phototherapy and oral Simvastatin in treatment of vitiligo A comparative study on the therapeutic effect of combined phototherapy and oral Simvastatin with phototherapy alone in patients with vitiligo 2016-07-22 anticipated 50 Complete https://irct.ir/trial/38511 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation software Ink was used to create a randomization table, Blinding description: In order to blind the investigator, medications were named A (simvastatin tablet) and B (Placebo). The patients were not aware of which drug they received. The groups were also coded A and B to the statistical analyzer. 2-3 Vitiligo. Intervention 1: Intervention group: The initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of Simvastatin (manufactured by Pursina Company) is 20 mg with the protocol of the 2 times a day in the first month, 3 times a day in the second month, and 2 tablets twice a day in the third and fourth months. Intervention 2: Control group: The initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of placebo (manufactured by Shiraz School of Pharmacy) is 20 mg with the protocol of the 2 times a day in the first month, 3 times a day in the second month, and 2 tablets twice a day in the third and fourth months. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: 6 month later To whom: Researchers Conditions: After publication of the extracted article of the clinical trial Where to obtain: Sending Email to the researchers How to obtain: Sending the request via the email Comments:
public Dr. Ladan Dastgheib
Shahid Faghihi Hospital, Zand street
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 dastghl@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Ladan Dastgheib
Shahid Faghihi Hospital, Zand street
Shiraz Iran (Islamic Republic of) 7134846114 +98 71 3212 5592 dastghl@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) The patients with vitiligo Age above 14 years old 14 years no limit Both Patients with systemic diseases Patients who use other therapeutic methods except light therapy Patients with any liver disease Patients with any kidney disease Pregnant and lactating women History of allergy to phototherapy Taking medication that has interactions with simvastatin L80 Vitiligo Treatment - Drugs Placebo Intervention group: The initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of Simvastatin (manufactured by Pursina Company) is 20 mg with the protocol of the 2 times a day in the first month, 3 times a day in the second month, and 2 tablets twice a day in the third and fourth months Control group: The initial dose of phothotherapy used in every patient is 100 mJ/cm2 and the energy is increased by 10 mJ/cm2 after every dose. The number of treatment sessions of phototherapy has been also determined three times a week. The dose of placebo (manufactured by Shiraz School of Pharmacy) is 20 mg with the protocol of the 2 times a day in the first month, 3 times a day in the second month, and 2 tablets twice a day in the third and fourth months The amount of melanin pigment in the skin. Timepoint: Assessment the amount of melanin pigment at the start of the study and at the end of the first, second, third and fourths month after beginning the treatment. Method of measurement: Vitiligo Area Scoring Index (VASI Score). Shiraz University of Medical Sciences Approved 2016-06-20 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)