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Stefano TOGNI 1, Giada MARAMALDI 1, Ivan PAGIN 1, Roberta CATTANEO 2, Roberto EGGENHOFFNER 3, Luca GIACOMELLI 3
1 Indena S.p.A., Milan, Italy; 2 Abich SrL, Verbania, Italy; 3 Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy
BACKGROUND: Quercetin, an ubiquitary flavonoid found in fruits and vegetables, showed marked antioxidant and anti-inflammatory properties in many in vivo and in vitro studies. Here, we investigated the safety and tolerability of a quercetin-based topical formulation (Quercevita®), already known to exert soothing and anti-itch effects.
METHODS: In this single blind trial performed on 25 healthy volunteers, a quercetin-phospholipids 2% cream was applied by an occlusive adhesive strip for patch test on the skin of the back, for 48 hours. In the phototoxicity assay, after patch removal, the tested skin area was exposed to UVA radiation. The skin reactions were evaluated according to defined parameters (erythema, desquamation, edema and vesicles) 15 minutes after patch removal (before irradiation), 15 minutes and 24 hours after irradiation. In the skin sensitization assay, an induction phase followed by a 10-day resting phase and by a 48-hour eliciting phase were carried out. Finally, skin allergic reactions were evaluated 15 minutes, 72 hours and 96 hours after patch removal.
RESULTS: Tested skin area was carefully examined and no skin reactions due to UVA exposure were observed for any evaluated parameters. Similarly, the tested product applied under occlusive conditions on the healthy skin of the volunteers, did not resulted to cause any allergic reactions at the defined observational periods. No other local or systemic adverse effects were observed.
CONCLUSIONS: These results indicate that the tested formulation containing 2% quercetin- phospholipids resulted to be neither photoirritant nor sensitizing within 96 hours after application. Therefore, this study provides evidence of the safety and tolerability of the quercetin-based topical formulation.