Double-blind randomised controlled trial of an emollient cream with and without 1 % supercritical CO2 extract of Calendula officinalis in contact dermatitis.

This double-blind randomised controlled trial aimed to evaluate the efficacy of an emollient cream with and without 1 % supercritical CO2 extract of Calendula officinalis in contact dermatitis. Twenty healthy volunteers without pre-existing dermatological conditions participated in this single-centre study. Each participant's forearm was divided into three test sites: control (no treatment), placebo (base emollient), and intervention (calendula cream). The study employed random allocation of test sites using Microsoft Excel software. Both investigators and participants were blinded to the treatment assignments. The main outcomes were changes in skin hydration and transepidermal water loss (TEWL), measured with non-invasive probes (Corneometer CM 825, Tewameter TM 300), and erythema measured by Mexameter MX 18. Following irritant exposure, all sites showed increased TEWL and reduced hydration, confirming skin barrier impairment. The intervention site demonstrated significantly greater hydration compared with both the control (p = 0.017) and placebo sites (p = 0.035) on day 4, with this improvement persisting on day 8 (p = 0.043). TEWL values at the intervention site were significantly lower than control on day 3 (p = 0.022), indicating faster barrier recovery. No significant differences in erythema were observed between groups, and no adverse events occurred. Results of this study indicate that the addition of 1 % Calendula officinalis extract to an emollient cream enhanced skin hydration and accelerated recovery after irritant exposure, suggesting potential benefit in managing contact dermatitis with non-pharmacological skincare formulations.