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Photodynamic therapy in inflammatory skin disease: Phase I results in adult healthy volunteers

The pharmacokinetics, efficacy, safety and tolerability of topical cis-urocanic acid (cis-UCA) were evaluated in 19 adult male healthy volunteers. Two single topical doses 1 week apart of 14 mg/kg of 5% cis-UCA emulsion or vehicle cream (BioCis Pharma, Finland) were applied in a randomized, double-blind design. The volunteers were then exposed to topical application of 20 ul of 100% DMSO to induce inflammation. Cis-UCA levels were below the limit of quantitation in plasma and urine (0.2 and 2 ug/ml, respectively), corresponding to baseline levels of endogenous cis-UCA. Transepidermal water loss was significantly reduced over 0.5-4.5 h (P = 0.014); erythema was also significantly reduced (P = 0.044) at 1 h after ...