Basic Fibroblast Growth Factor (bFGF) related decapeptide 0.1% Solution, with Tacrolimus 0.1% ointment combination therapy compared with Tacrolimus 0.1% ointment monotherapy in the treatment of stable vitiligo: A Phase IV, randomized 12 months Study

Background: Basic Fibroblast growth factor (bFGF) increases proliferation of melanocytes in the pigmentation of vitiligous area. Tacrolimus is well established topical immunomodulator with action at multiple immune as well as inflammatory pathways. The combination of treatment modalities acting via different mechanisms have proven beneficial in management of vitiligo Materials and Methods: A phase IV, randomized, open label, non-comparative, prospective, multicenter study conducted among patients with stable vitiligo to evaluate efficacy and safety of topical combination of bFGFrP and tacrolimus in comparison with tacrolimus monotherapy. The efficacy assessment parameters after 12 months of treatment were, improvement in extent of repigmentation (EOR), grade of repigmentation (GOR), patient global assessment (PGA). Results: Out of 120 randomized patients, at the end of the study, after 12 months of treatment, the combination group (bFGFrP + T) showed significant improvement in EOR with 66.7% patients (n=54) achieving greater than 50% of repigmentation as compared to only 39.2% in tacrolimus group (n=51). Significantly higher mean response rate (66.75%) was observed in combination group than tacrolimus monotherapy group (46.47%). Conclusion: After 12 months of treatment, combination of bFGFrP and Tacrolimus leads to significantly better results with rapid repigmentation and response rates in stable vitiligo patients, with a favorable safety profile. © 2020 Published by Innovative Publication. This is an open access article under the CC BY-NC license (https://creativecommons.org/licenses/by-nc/4.0/)