Case Study 2
Skimune®Cosm is specifically designed for use in the cosmetic industry and can detect tissue damage resulting from cytokine release from stimulated immune cells in response to cosmetic actives or compounds.
Our client is involved in development of cosmetics using natural ingredients. Alcyomics was engaged to help generate human safety data and assess any potential adverse immune responses of a novel product (product X) prior to first use in man.
Product X had been developed for topical application, therefore the effect of repeat dosage of product X was investigated in the presence of immune cells. Alcyomics demonstrated that this product had the potential to cause an adverse immune response and therefore not safe in its present formulation for human application. For this client we also provided T cell proliferation assays which correlated with, and confirmed, the Skimune®Cosm results.
The data shows the usefulness of our screening assays (T cell proliferation assays) and Skimune®Cosm assay in the development of cosmetic actives or compounds.
Figure 1: Analysis of Product X repeat dose after three days using Skimune®Cosm
Skimune®Cosm was used to investigate the topical formulation product X after a 2 day and 3 day incubation, to investigate repeat dose exposure. A Grade III positive response was observed after 2 days (top left) and a more extensive subepidermal cleft formation amd Grade III positive response after three days (top right). Positive response is indicated by damage between the dermal-epidermal junction (highlighted by black arrows). These data indicated Product X was not safe in the current formulation for human use. Negative control showed a Grade I negative response (bottom left) and the positive control a Grade IV positive response (bottom right).