Comparison of two betamethasone oral mini pulse regimens plus topicals versus topicals alone in rapidly progressive non-segmental vitiligo: a randomized three-arm clinical trial

The study is proposed to be a multi-arm randomized controlled trial which will compare the efficacy of two different dosing regimens for achieving disease arrest, when given along with topical treatment, in rapidly progressive vitiligo which in this study will be defined as the development of more than 5 new lesions in the past 1 month, of the development of more than 15 new lesions in the past 3 months.

Betamethasone oral mini pulse oral mini pulse is given as either 2.5 mg once daily on two consecutive days of the week, or 5 mg once daily on 2 consecutive days of the week. Various studies in the past, including multiple randomized controlled trials, and a systematic review, have shown that OMP can halt disease progression in about 80% of patients. No study in the past has directly compared these dosing regimens against each other. Additionally, disease arrest rates will be compared with a third arm receiving only topical treatment, at the end of 12 weeks.

The study will be conducted at the outpatient department of Dermatology & Venereology and Pigmentation Clinic, All India Institute of Medical sciences after ethical clearance from Institutional Ethics Committee for Postgraduate Research of the All India Institute of Medical Sciences, New Delhi, and registration of the study protocol with the Clinical Trial Registry India.

The sample size of this study is 75, and the patients will be allocated in a 2:2:1 allocation ratio, such that 30 patients will receive 2.5 mg OMP twice weekly, 30 patients will receive 5 mg OMP twice weekly, and 15 patients who receive topical treatment.

Recruitment will be based on a set of pre-designed inclusion and exclusion criteria, and after recruitment, patients will be randomized through block randomization using a statistical software, into three arms. Two of the arms will receive either 2.5 mg OMP once daily, on two consecutive days of the week, or 5 mg OMP once daily on two consecutive days of the week for a period of 24 weeks. The third arm will receive topical treatment (0.1% tacrolimus/0.1% fluocinolone acetonide) for a period of 12 weeks, followed by re-randomization of this arm into either one of the arms at the end of this period, in a 1:1 ratio.

Relevant investigations will be carried out at baseline and throughout various designated time periods during the course of this study.

The primary outcome will be proportion of patients with disease arrest (no new lesion and no progression of pre-existing patches) at week 12, maintained till week 24 (compared using either Chi-square or Fisher test). Multiple secondary outcomes including change in quality of life and repigmentation rates among the arms will be measured.