Ramaiah A, Kar HK, Vijay Kumar Garg, Neeraj Bajaj, Lipy Gupta and Madhava AS
Back ground: Topical application of bFGF related deca peptide followed many hours after with sun /UVA exposure was found effective in the earlier conducted clinical trials to treat Non-segmental, segmental, PUV-A resistant and fast spreading vitiligo either by itself or in combination with PUV_A, or oral steroids. The deca peptide lotion is marketed in India since 2004 to treat vitiligo.
Objectives: A multicentre randomized double blind phase IV clinical trial on bFGF related deca peptide to treat vitiligo was conducted with the following twin objectives. One was to evaluate the efficacy and safety of topically applied deca peptide in vehicle in combination with narrow band ultra violet light (NBUVB) in patients with vitiligo. The second objective was whether deca peptide is effective to repigment vitiligo macules on sun protected areas without sun exposure.
Methods: This was a multi-centre study. Two chosen macules on each patient that were non-sun exposed areas on patients with stable non segmental vitiligo were selected. The duration of treatment of volunteers was for 3 months starting with or without the topical application of deca peptide in vehicle on 30 volunteer patients with NBUVB and on 32 volunteers with deca peptide in vehicle.
Results: The results demonstrated that with NB-UVB plus deca peptide in vehicle group, 9 patches out of 30 repigmented by more than 40% compared to only 5 out of 62 patches treated with NBUVB alone and with peptide alone groups indicating that NBUVB and peptide act synergistically in repigmentation of the macules. In addition, the mean value of repigmentation at the end of 3 months in all the 30 macules of 30 patients with NBUVB+ peptide was 229 mm square compared to only 90 only with NBUVB in vehicle alone. More repigmentation occurred with NBUVB+ peptide at all-time points of evaluation. Conclusions: The results demonstrated that NB-UVB plus deca peptide act synergistically and produced more repigmentation of the macules right from the start compared to control even though deca peptide application was in effect for 3 days in a week. NBUVB+ peptide was superior to NBUVB alone in repigmenting vitiligo macules. The deca peptide in absence of sun exposure of vitiligo macule may not be as effective to repigment vitiligo macules as with sun exposure. NBUVB and peptide were well tolerated.
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Journal of Dermatology and Dermatologic Diseases received 4 citations as per Google Scholar report
