A comparative study to evaluate the efficacy and safety of dinoprostone and tacrolimus following dermabrasion in the treatment of stable vitiligo.

Dermabrasion is a commonly used surgical modality in thetreatment of stable vitiligo. This minimal invasive method can be combined withvarious topical therapies for better drug penetration hence better results.As vitiligo is proposed to be a result of autoimmunity, topicalimmunomodulator drugs like Calcineurin inhibitors like pimecrolimusandtacrolimus are used in treatment of vitiligo. There is increasedexpression of various Prostaglandin receptors like Prostaglandin E2(PGE2) type1and 3 over melanocytes. PGE2 analogue like Dinoprostone was used in thetreatment of vitiligo in the year 2002. Combinationof dermabrasion and topical agents have given better results in few clinicalstudies.                       Here the aim of study isto compare and evaluate Tacrolimus and Dinoprostone following dermabrasion inthe treatment of stable vitiligo using VASI (Vitiligo Area Scoring Index) andrecord adverse effects if any.  Based on the previous study conducted by Kaur J et al, after 24 weeks, Grade 4 repigmentation in Group A and Group B are 25% and 0% respectively, sample size was calculated and found to be 52. After obtaining approval and clearance from the institutional ethics committee, the patients fulfilling the inclusion criteria will be enrolled for the study after obtaining informed consent. A detailed clinical history will be taken in terms of demographic data, age, sex, occupation, presenting complaints, past history, treatment history, family history duration of skin lesions, course and progression of disease and clinical examination findings will be recorded in the case record form. Appropriate photographs will be taken at each visit with informed consent. After detailed history taking and thorough clinical examination, patients diagnosed with Stable Vitiligo will be allocated into two study groups of 26 each, randomized in 1:1 ratio using computer random sequence generator. Patients in both groups A and B will be taken up for Dermabrasion and following steps will be done: ·       A desired area of depigmented vitiligo patch is selected. ·       Patch is sterilized using povidine iodine solution. ·       Patch is anesthetized using 2% lignocaine injection. ·       Using Manekshaw’s dermabrader, dermabrasion is done 3-4 times in each direction horizontally, vertically and diagonally until pinpoint bleeding occurs. ·       Hemostasis is achieved and following treatment is given for each group. a.     Group A patients will be taken up for tacrolimus 0.1% ointment application. b.     Group B patients will be taken up for Dinoprostone 0.5mg/3g gel application.After application of topical creams, dressing is done. Patients are advised to remove dressing after 24 hours and then are advised to apply tacrolimus 0.1% ointment twice daily and Dinoprostone 0.5mg/3g gel twice daily in group A and B respectively. Patients will be given oral analgesics, Tab.Paracetamol 500mg, as needed. This drug does not interfere with the topicals used in the study. Patients will be followed up on Day 3 and Day 7 for assessment of any side effects.  VASI (Vitiligo Area Severity Index) will be assessed at weekly intervals from week 4 to 24 along with simultaneous serial digital photographs and recording of side effects if any.