Safety assessment of two moisturizer products: Phase I controlled clinical trials

Moisturizers have important roles in the treatment of dry skin. Their safety has to be evaluated on human volunteers in order to assess their potential skin irritation. Measurements of skin biophysical parameters can be used as fast and noninvasive methods to assess any harmful effect of cosmetic formulations on the skin sites where those products are applied. Two moisturizers were selected from Iran's market to determine the changes in Trans Epidermal Water Loss (TEWL), stratum corneum hydration, pH, melanin and hemoglobin contents by biometric assessments with MPA 580 Cutometer®. There was no any significant change in TEWL, skin pH, melanin and hemoglobin contents before and after products application. Stratum corneum hydration was increased after application of Neu Derm Renutrive Honey Shea from 0.09 to 0.39 (P0.001). Neu Derm Optimal Hydrosense increased stratum corneum hydration from 0.23 to 0.48 (P0.001). Application of the studied moisturizers on human volunteers did not show any adverse effect. So, those products could be recommended for safe use. Significant changes in the stratum corneum hydration associated with application of each moisturizer were related to humectant ingredients which were used in each product.