COMPARATIVE STUDY ON THE EFFICACY OF SAFUF-I BARAS AND NARROW BAND ULTRA-VIOLET B PHOTOTHERAPY IN BARA? (VITILIGO)- STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL

Dr. Meenu Doni* and Prof. Mohd. Aleemuddin Quamri

ABSTRACT

Background and objectives: Baraṣ (Vitiligo) is an autoimmune skin disorder that is characterized by patches of skin that lose pigments because of dysfunctional pigment-producing melanocytes being attacked by immune cells. Its exact etiopathogenesis is unknown. We here present the protocol of an interventional clinical phase II study to test the hypothesis, that Safūf-i Baraṣ alone and in combination with NB-UVB phototherapy may be effective among the cases of Non-Segmental Vitiligo. Methods: It is a Randomized Open-labelled Triple Arm Comparative Clinical Trial.150 patients with clinically diagnosed non-segmental vitiligo will be randomized to Group A (n=50), Group B (n=50) and Group C (n=50). In group A Safūf-i Baraṣ will be given Orally in the form of Zulāl and sediment is applied on selected lesions followed by exposure to sunlight daily for 20 minutes, for 60 days. In Group B only NB-UVB Phototherapy will be given on alternate days locally on the selected lesion for 60 days and in Group C Safūf-i Baraṣ will be given Orally in the form of Zulāl daily and NB-UVB Phototherapy will be given on alternate days for 60 days. The primary endpoint is the reduction in Vitiligo Extent Tensity Index (VETI) and Vitiligo Area Scoring Index (VASI) score. Secondary endpoints include changes in photographic lesions (re-pigmentation) and Improvements in the Dermatological Life Quality Index (DLQI).

Keywords: Baras, Saf?f-i Bara?, NB-UVB phototherapy, Non-segmental vitiligo, VASI,VETI,DLQI.