Therapeutic effects of topical fluorouracil on vitiligo lesions

Evaluation of therapeutic effect of 5 Fluorouracil on vitiligo lesions

The study will be performed on 25 patients who have inclusion criteria. 3 lesions will be selected in each patients .Patients selection is non-randomized, however the lesions in each patient will be chosen according to simple randomized method of closed envelop.

The study will be held in dermatology clinic of Emam Reza Hospital, Mashhad, Iran. As patients are aware to the therapeutic procedures, patients and the researcher are not blind to the allocation. Pigmentation assessors as well as analyzer are blind to the group allocations. In each patient, 3 lesions will be selected. Microneedling with Dermapen will be done on two depigmented lesions . the first lesion will also undergo close dressing of 5 fluorouracil for 30 minutes. The third lesion will remain with no treatment. The procedure will be done each 2weeks for 3 months. After each session a photograph will be taken from the lesions. Re-pigmentation will be scored by two blinded dermatologist as follows: 0-25% pigmentation:1; 25-50% pigmentation:2; 50-75% pigmentation :3; 75-100% pigmrntation: 4.

Entrance criteria: patients over 10 years of age ; refractory lesions to 3 months NB-UVB therapy; Lesions should be distal to elbow/knee (except palms and soles) Non-entry criteria: active coebner phenomenon ; active infection at the lesion site ; serious systemic illness

First lesion undergoes microneedling plus 5FU dressing for 30 minutes. Secound lesion undergoes only microneedling. The third lesion leave without treatment.

Re-pigmentation percent; Re-pigmentation start time; Re-pigmentation pattern

Randomization is based on a table of random numbers. First ,we prepare a random list as follows:. 3lesions will be choosen in every patients, for the three modalities, we will have following conditions: 1) Lesion 1treatment N, lesion 2 treatment NF, lesion 3control. 2) Lesion 1 treatment NF, lesion 2 treatment N, lesion 3 control 3) Lesion 1control, lesion 2 treatment N, lesion 3treatment NF 4) Lesion 1control, lesion 2treatment NF, lesion 3treatment N 5) Lesion 1treatment N, lesion 2control, lesion 3 treatment NF 6) Lesion 1treatment NF, lesion 2control, lesion 3 treatment N Each of these arrangements is placed in a sealed envelope. Then, based on the table of random numbers, the envelopes are given to patients. We begin from a point in table of random numbers and write the numbers and ignore numbers greater than 6 , continue to reach the desired sample size . Give every patient the determined envelope. For example consider the numbers from the table: 5179483 First patient envelope 5 , secound patient envelope 1, ignore the 7and 9 , third patient envelope 4 and ....

The assessors who score the pigmentation after therapeutic procedure as well as the analyzer will be blind to the allocation.

No further data are available

Written informed consent as well as analytical file and final study report could be shared by the authors.

Data will become available 3 months after the study

Academic researchers

No change should be performed on available data

Applicant should make communication by IRCT secretariat or personal E-mail

Applicant should make communication by IRCT secretariat or personal E-mail

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