]>
IRCT20200714048099N1 IRCT 2020-08-30 Kerman University of Medical Sciences Assessing effectiveness of adding topical atorvastatin to vitiligo treatment Assessing effectiveness of adding topical atorvastatin 1% ointment to topical calcineurin inhibitor treatment for nonsegmental vitiligo patients visited at Afzalipour hospital dermatology clinics 2020-11-21 anticipated 20 Complete https://irct.ir/trial/49710 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using table of random numbers, 10 patients will be allocated to each of the intervention and control groups. The intervention group will receive neosomal atorvastatin 1% oint and topical neosomal tacrolimus treatments. The control group will receive placebo oint and topical neosomal tacrolimus treatment. Each participant will be given a number from 1 to 20. One row and one column will be randomly chosen from the table of random numbers; the intersection between this row and column will be the starting point for sampling. A finger will be put on the starting point and will be moved downwards through the table. Because there should be 10 participants in the intervention group and 10 participants in the control group, the two digits at the right side of each number in the table will be considered. The moving of finger will be repeated until 10 participants of the intervention group will be chosen. Duplicate numbers and numbers larger than 20 will not be considered. In this way, it will be found out that which 10 numbers among all of the 20 numbers given to the whoke participants will be allocated to the intervention group (e.g. numbers 3, 4, 9, 11, 13, 14, ...). The remaining 10 participants will be automatically put in the control group. After randomization, each of the 20 numbers will be matched with one of the treatment arms. Each treatment arm will be allocated the letter A or B and these letters will be put in an opaque and sealed pocket. Each patient will receive her/his treatment based on the allocated pocket. The only peron who is aware of the allocated arm will be the operator who will not be involved in other part of the trial, Blinding description: Letters A or B will be allocated to each treatment arm. The only person aware of what treatment is specified to each of the groups will be the operator who will be responsible for handing in the treatments to the patients. Patients, physicians and the analyzer of the final data will not be aware of the content of groups A and B. 2-3 Vitiligo. Intervention 1: Control group patients will receive a topical placebo oint (similar in appearance to neosomal atorvastatin 1% oint) together with topical neosomal tacrolimus oint to be used twice daily for 3 months. Intervention 2: Intervention group will receive topical neosomal atorvastatin 1% oint together with topical neosomal tacrolimus oint to be used twice daily for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There are no more information.
public Rezvan Amiri
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway
Kerman Iran (Islamic Republic of) 7616913555 +98 34 3132 5856 rezvanamiri1358@yahoo.com Kerman University of Medical Sciences scientific Hamed Zartab
Afzalipour Hospital- Imam Khomeini Highway
Kerman Iran (Islamic Republic of) 7616913911 +98 34 3132 8000 Hzartabmd@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) A diagnosis of non-segmental vitiligo made by the attending dermatologist who first visits patient at the Afzalipour Hospital's dermatology clinic Filling out and signing the written informed consent form by the patient Patient's age of at least 18 years at the time of signing the informed consent Male or nonpregnant and nonbreastfeeding female 18 years no limit Both Any dermatologic disorder other than vitiligo; infectious disorders; inflammatory disorders; diabetes mellitus; cardiovascular disorders; renal disorders; liver disorders; endocrinologic disorders; autoimmune disorders; any other uncompensated medical disorder A diagnosis of segmental vitiligo made by the attending dermatologist who initially visits patient Pregnancy or breastfeeding History of hypersensitivity to atorvastatin Using any type of drugs of statin group during the 8 week period immediatly before starting the trial Using systemic immunosuppressive or immunomodulator treatments (cyclosporin A, corticosteroids) during the 4 week period immediatly before starting the trial or using azathioprine, methotrexate, mycophenolate mofetil, or janus kinase inhibitors during the 8 week period immediatly before starting the trial Phototherapy as a treatment of vitiligo or any other disorder during the 4 week period immediatly before starting the trial Alcohol or illicit drug use History of dermatologic malignancy during the 5 year period immediatly before starting the trial or current dermatologic malignancy Being involved in any other clinical trial Noncompliant patient L80 Vitiligo Treatment - Drugs Treatment - Drugs Control group patients will receive a topical placebo oint (similar in appearance to neosomal atorvastatin 1% oint) together with topical neosomal tacrolimus oint to be used twice daily for 3 months. Intervention group will receive topical neosomal atorvastatin 1% oint together with topical neosomal tacrolimus oint to be used twice daily for 3 months. Vitiligo Area Scoring Index (VASI). Timepoint: At the beginning of the study (before any intervention) and 3 months after the start of study interventions. Method of measurement: VASI is defined as the product of hand units (each hand unit equals 1% body surface area involvement) times depigmentation pattern in each measured area. Treatment side effects. Timepoint: Throughout study period and up to 3 months after the start of the study. Method of measurement: History taking and physical exam. Patient's satisfaction. Timepoint: Three months after the start of the study. Method of measurement: Asking patient to score her/his satisfaction on a scale of 0 to 10. Any association between laboratory abnormalities and treatment type. Timepoint: At the beginning and at the end of the study (3 months after start of the study). Method of measurement: Blood test and measuring serum levels of variables. Kerman University of Medical Sciences Approved 2019-11-24 Research Ethics Committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman, Postal Code: 7616913555, Iran Kerman Kerman Iran (Islamic Republic of)