Assessing effectiveness of adding topical atorvastatin 1% ointment to topical calcineurin inhibitor treatment for nonsegmental vitiligo patients visited at Afzalipour hospital dermatology clinics

Determining and comparing treatment effectiveness in the two arms of trial according to VASI, and associations with age, gender, family history, disease duration, vitiligo type and disease location, side effects, patients' satisfaction, and possible associations between any abnormal laboratory result and treatment type in the two arms of trial.

Two arms, parallel groups, randomized controlled, triple blinded clinical trial

The stusy will be done on 20 patients visited at Kerman Afzalipour Hospital dermatology clinic. Patients will be randomly allocated into two arms and will receive either neosomal atorvastatin 1% oint or placebo oint, plus neosomal tacrolimus oint twice daily for 3 months.

Inclusion criteria Diagnosis of nonsegmental vitiligo made by the attending dermatologist Age of at least 18 years at the start of the study Male or nonpregnant, nonbreastfeesing female Noninclusion/exclusion criteria Any other cutaneous or internal disease Segmental vitiligo Pregnancy or breastfeeding History of any type of hypersensitivity reaction to atorvastatin Statin use in the previous 8 weeks Systemic immunosuppressive or immunomodulator therapy (steroids, cyclosporin A) in the previous 4 weeks or using azathioprine, mycophenolate mofetil, methotrexate, or janus kinase inhibitors in the previous 8 weeks Phototherapy in the previous 4 weeks Alcohol or drug abuse History of cutaneous malignancy in the recent 5 years or having a current cutaneous malignancy Participafing in any other clinical trial Noncompliant patient

Intervention: neosomal atorvastatin 1% oint plus neosomal tacrolimus oint. Control arm: placebo oint plus neosomal tacrolimus oint.

VASI change

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.

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.

There are no more information.