Activity of Chitin Nanofibrils Block-Copolymers Entrapping Zn/Al/SA/Allantoin on Seborrheic Dermatitis. A randomized double-blind placebo controlled study

Summary Background: The study was designed to evaluate the topical efficacy and safety of chitin nanofibrils antrapping Zn, Al, salicylic acid (2%) water solution and allantoin combined with the activity of a shampoo based on a Zn based cleansing agent, in the treatment of scalp seborrhoic dermatitis as newly therapy for seborrhoeic dermatitis, preventing sebum-reducing, anti-inflammatory and antimicrobial and antimicotic activity. Method: A double-blind placebo, 60 patients with scalp seborrhoic dermatitis were treated by a16 week trial. Efficacy was determined in vivo by the control of population density of P. ovale and S. aureus, dandruff scales, and reduction of surface lipids and free fatty acids/triglycerides ratio. The anti-inflammatory activity of IL-8, IL-1α and TNF-α and the antioxidant activity on ROS, was verified in vitro. Safeness of the treatment was evaluated by questionnaire at each visit. Results: For all the subject treated by the active solution and Zn shampoo the total symptoms significantly improved at week 4 maintaining the activity. Moreover, from week and until week 16, S. aureus, P. ovale, surface lipids and FFA/triglycerides ratio presented a continuous reduction throughout the study maintaining their normal values during the suspension period also. Conclusion: SA water solution complexed by chitin nanofibrils with Zn Al ions and allantoin, seems to be an innovative and effective therapeutic option for scalp seborrhoic dermatitis.