title: Randomized controlled trial of a water-soluble nail lacquer based on hydroxypropyl-chitosan (HPCH), in the management of nail psoriasis.
abstract: BACKGROUND
  Nail psoriasis occurs in up to 50% of patients affected by psoriasis, with a significant impact on quality of life that leads to a real clinical need for new therapeutic options.
  
  
  OBJECTIVE
  To confirm whether the strengthening and hardening properties of the hydroxypropyl-chitosan (HPCH) nail lacquer could improve the structure of the nail plates on psoriatic nails.
  
  
  METHODS
  A randomized, double-blind, placebo controlled, parallel-group trial was carried out to evaluate the efficacy and tolerability of a hydrosoluble nail lacquer containing HPCH, Equisetum arvense, and methylsulfonylmethane on nail psoriasis. The test product or a placebo was applied once daily for 24 weeks to all fingernails. Efficacy assessments were performed on the target fingernail by means of the modified Nail Psoriasis Severity Index score. A cut-off score of 4 was considered to define the clinical cure rate (ie, Cure ≤4, Failure >4).
  
  
  RESULTS
  After 24 weeks, the clinical cure rate showed the statistically significant superiority of the HPCH nail lacquer compared to placebo in both the intention-to-treat (Fisher's exact test, P=0.0445) and the per protocol population (Fisher's exact test, P=0.0437). This superiority was already present after 16 weeks of treatment. Moreover, the analysis of the modified Nail Psoriasis Severity Index-50 showed a statistically significant clinical improvement after 12 weeks of treatment in comparison to the results obtained after 8 weeks (Fisher's exact test, P<0.05).
  
  
  CONCLUSIONS
  The trial showed that HPCH nail lacquer could be a new, valid, effective, and safe option for decreasing the signs of nail dystrophy in psoriatic patients.
authors.affiliation: Department of Dermatology, Sapienza University, Rome, Italy.
authors.forename: Franca
authors.initials: F
authors.lastname: Cantoresi
authors.affiliation: Scientific Department, Polichem SA, Lugano, Switzerland.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Caserini
authors.affiliation: Department of Dermatology, Sapienza University, Rome, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Bidoli
authors.affiliation: Department of Dermatology, Sapienza University, Rome, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Maggio
authors.affiliation: Department of Dermatology, Sapienza University, Rome, Italy.
authors.forename: Raffaella
authors.initials: R
authors.lastname: Marino
authors.affiliation: Department of Dermatology, Sapienza University, Rome, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Carnevale
authors.affiliation: Department of Dermatology, Sapienza University, Rome, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Sorgi
authors.affiliation: Scientific Department, Polichem SA, Lugano, Switzerland.
authors.forename: Renata
authors.initials: R
authors.lastname: Palmieri
keywords: nail psoriasis; psoriatic onychodystrophy