Oral communication, CS22 / C110

Official XXIst International Pigment Cell Conference website - 21-24 Sept 2011, Bordeaux - France | updated: September 04 2011

Double blind randomized clinical trial on bFGF related deca peptide to treat vitiligo

BACKGROUND: Combination of Topical application of bFGF related deca peptide with sun / UVA exposure was found effective in the earlier conducted open ended clinical trials to treat Non-segmental, segmental, PUV-A resistant and fast spreading vitiligo either by itself or in combination with PUV_A, or with oral steroids. The deca peptide lotion is marketed in India since 2004 to treat vitiligo. OBJECTIVES: A multicentric randomized double blind phase 1V clinical trial on bFGF related deca peptide to treat vitiligo was conducted in Delhi during 2009 to evaluate the efficacy and safety of topically applied deca peptide alone and in combination with Narrow band ultra violet light (NB-UVB) in patients with non segmental vitiligo. METHODS: The chosen vitiligo macules were non-sun exposed areas on patients with stable non segmental vitiligo. The trial was conducted for 3 months on 30 volunteer patients with NB-UVB alone or plus peptide group and an equal number with deca peptide applied group with peptide alone or vehicle alone. This research was conducted in accordance with the principles enunciated in the Declaration of Helsinki (Ethical Principles for Medical Research involving Human subjects revised in 2008.The pigmentation of the macules before and after treatment were measured objectively by Canfield Inc proprietary soft ware. RESULTS: The change from base line macule area over time for macules treated with Peptide and NB-UVB indicated an earlier and more dramatic response than control. Peptide and NB-UVB act synergistically and repigmented the vitiligo macules far better than either of them alone with statistical significance by Chi square statistical method. CONCLUSION: It was concluded that the results with NB-UVB plus deca peptide is far superior to NB-UVb alone and that it may be further improved by application of the deca peptide many hours after the NB-UVB radiation rather than soon after the radiation treatment as was done in the present trial. The peptide and NB-UVB treatment was well tolerated and safe.

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