Objectives:
To compare the effect of topical piperine combined with narrow band UVB on vitiligo treatment with narrow band UVB alone.
Design:
Double-blind randomized clinical trial
Setting and conduct:
In this double-blind randomized clinical trial, patients with vitiligo in the facial region referring to Loghman Hakim and Shohada-e-Tajrish hospitals during 2014 to 2016 were invited for participation. Included subjects will be randomly assigned to the two treatment and placebo groups.
Participants:
Inclusion criteria included patients with facial vitiligo. The exclusion criteria were as follows: a history of an autoimmune disease such as alopecia areatea, diabetes, Addison's disease, pernicious anemia, Graves' disease, Hashimoto’s thyroiditis, systemic lupus erythematosus, and a history of treatment with NB-UVB in the last two weeks, or a history of the use of topical medications for at least 2 weeks prior to the study. Accordingly, a total of 63 patients were selected as the sample population for this study and randomly assigned to two groups of placebo (28 subjects) and piperine (35 subjects).
Intervention:
The case and control groups participated in this study will be treated by topical piperine and placebo respectively for three months. It is worth noting that the standard phototherapy treatment (NB-UVB) will be given in both groups during this time. Piperine solution (1%) will be prepared by dissolving the piperine (with 95% purity, provided from Bioprex Co., India) in a solvent mixture [dimethyl sulfoxide (DMSO): isopropyl alcohol and glycerol] (20: 80).
Patients in both groups will undergo NB-UVB phototherapy by Waldman UV 7001 German device for three months, every other day. The energy of the device will be set on 0.05 Joules at the first session and 0.05 Joules will be added to each session to attain a maximum level of 2 Joules and then this energy will be kept constant for further procedure.
Main outcome measure:
The level of repigmentation scored on a scale of 0 to 100 by the subjects along with two blinded dermatologists will be the main outcome measure. Score 0 means full depigmentation, and 100 is equal to normal skin. Evaluations will be conducted at one, two and three months.