RESULTS USING MELANODERM™, AN EPIDERMAL MODEL CONTAINING FUNCTIONAL MELANOCYTES, DEMONSTRATE EFFICACY OF NOVEL SKIN LIGHTENING FORMULATIONS.

To minimize the cost of human clinical studies and shorten the time to market, we have used the MelanoDerm skin model (MatTek Corporation) to screen novel skin lightening formulations that we have recently developed. The formulations were applied topically to MelanoDerm tissues 5 times over an 8-day period. Tissue samples were fixed for histological analysis on Days 4, 7, 11, and 14; others were frozen on Days 11 and 14 to measure melanin content. Visual observation of the tissues showed that the tissues progressively darken over the 14-day culture period and that the 4 formulations tested resulted in significantly decreased pigmentation versus the negative control (untreated) tissues. This was borne out by melanin assay results that showed decreases of 64-77% in melanin content versus the controls. Histological analysis showed that the tissues maintained normal epidermal morphology over the experimental period and that the reduction in pigmentation was not due to cytotoxicity. Using en face microscopic observation, the melanocytes were difficult to visualize in the treated tissues up through Day 11. However, 6 days after the final lightener application (Day 14), the melanocytes in tissues treated with 3 of the 4 formulations were highly pigmented and dendritic, similar to the melanocytes contained within the control tissues. Based on these results, we conclude that 3 of the 4 formulations dramatically inhibit melanogenesis without cytotoxicity. These and initial, positive clinical results lead us to believe that the formulations will be commercially useful in skin lightening products.

Chloasma, Hydroquinone, Hyperpigmentation, MelanoDerm, Melanocyte, Melasma, Senile lentigo, Skin model