A Double Blind Randomized Clinical Trial on Basic Fibroblast Growth Factor Related Deca-Peptide to Reduce Wrinkles on Skin and to Treat Non Sun Exposed Vitiligo Macules

Abstract Background: Topical application of basic Fibroblast Growth Factor (bFGF) related decapeptide followed by sun exposure/UVA phototherapy was found effective in repigmenting vitiligo lesions in the earlier conducted clinical trials. The decapeptide lotion was approved by Drug Controller General India (DCGI) and marketed in India since 2004 to treat vitiligo. Objectives: A multicentre randomized double blind clinical trial on bFGF related deca peptide was conducted with the following twin objectives. • Whether the repigmentation of vitiligo macules of non-sun exposed areas occur without sun exposure after its application. • Whether it is effective to reduce wrinkles/fine lines on skin as indicated in earlier open ended trial. The vitiligo macules were selected on non-sun exposed areas of skin. Methods: The multicenter study was carried out in patients (n=32) with stable non-segmental vitiligo that were selected by dermatologists. Two non-contiguous vitiligo macules on each patient which were non-sun exposed areas were selected for application of deca-peptide and vehicle control. The duration of treatment of volunteers was for 3 months starting with topical application of deca-peptide in vehicle on one macule of volunteers and vehicle control on the other macule of the same volunteers. Results: The results demonstrated that decapeptide in vehicle group resulted in visible reduction of wrinkles and fine lines on the macules compared with the corresponding controls confirming the results of open ended trial on normal volunteers. The repigmentation of decapeptide in vehicle treated macules is about the same as the control vehicle treated macules. Conclusions: The results demonstrated that the deca peptide lotion can be used as a cosmetic to reduce wrinkles/fine lines on skin. In absence of sun exposure, the topical application of decapeptide on the non-sun exposed vitiligo macules was not as effective to repigment as in the earlier conducted clinical trial where the sun exposed vitiligo macules were exposed to sun after its application.