Safety assessment of anti-dermatitis creams by measuring the biophysical parameters of skin: Phase I clinical trial with control group

Dermatitis or eczema is an itchy skin disorder which is usually caused by the skin inflammatory reaction in response to combination of genetic and environmental factors. This study was aimed to assess the safety of anti-dermatitis creams and possible side effects on human volunteers through measuring the skin biophysical parameters with non-invasive methods.
Two groups of 15 adults and 15 children as healthy volunteers participated for safety assessment of three anti atopic and contact dermatitis creams. All measurements were done using Cutometer® MPA 580 and the changes in the rate of transepidermal water loss (TEWL), stratum corneum hydration, content of melanin and hemoglobin (erythema) and skin pH were recorded. The obtained data were analyzed using SPSS software version 20 and P In this trial, no statistically significant changes in skin biophysical parameters including TEWL, melanin, erythema and pH was observed. The stratum corneum hydration on the applicatioins areas of Dermalex Repair Eczema, Dermalex Repair Contact Eczema, Dermalex Repair Eczema for Babies & Children compared to the control sides were significantly different (P=0.002, 0.001 and 0.013). This significant difference was due to emollient or humectant compounds in these creams.
Because of no adverse changes in the skin biophysical parameters, the studied anti-dermatitis creams could be conisdered as safe products. In addition, due to self-assessment results of adverse effects by the participants, no significant adverse effect was seen.