title: Preliminary open-label clinical evaluation of the soothing and reepithelialization properties of a novel topical formulation for rosacea.
abstract: BACKGROUND
  Rosacea is a common, incurable skin barrier disorder characterized by relapses and remissions.
  
  
  OBJECTIVE
  To evaluate the efficacy of Farmaka Rosacea Cream (FRC), a novel topical formulation for rosacea.
  
  
  METHODS
  This single-center, open-label pilot study comprised a single-dose substudy in 20 healthy subjects and a long-term, repeat-dose substudy in 22 subjects with rosacea. The 2-hour, controlled, single-dose substudy assessed the soothing and reepithelialization properties of FRC after stripping-induced erythema based on the erythema index, transepidermal water loss, skin hydration, and clinical assessments of erythema. In the long-term substudy, subjects applied FRC twice daily for 8 weeks. Clinical assessments included vascular and pigmentary homogeneity and erythema and hemoglobin indices. Subjects completed questionnaires to assess FRC efficacy and cosmetic acceptability.
  
  
  RESULTS
  Greater reductions were seen in FRC-treated areas compared with untreated areas for the erythema index (-16% versus -8%; P<0.001) and mean transepidermal water loss (-35.8% versus -10.1%; P<0.001) 30 minutes after stripping. Significant improvements over untreated areas were maintained 2 hours after stripping. Skin hydration and clinical erythema assessments also indicated that FRC soothed rosacea symptoms and promoted skin reepithelialization. Erythema and hemoglobin indices were significantly reduced from baseline after 4 and 8 weeks of treatment. Clinically assessed parameters were significantly improved following FRC application. Subjects assessed FRC positively.
  
  
  CONCLUSIONS
  Improvement of rosacea symptoms was noted with FRC application. The main film-forming ingredients of FRC (trehalose, cholesterol, ceramide, and fatty acids), combined with other soothing and calming ingredients and ultraviolet filters, could explain its efficacy.
authors.affiliation: Derming Srl, Monza, Italy.
authors.forename: Adele
authors.initials: A
authors.lastname: Sparavigna
authors.affiliation: Derming Srl, Monza, Italy.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Tenconi
authors.affiliation: Derming Srl, Monza, Italy.
authors.forename: Ileana
authors.initials: I
authors.lastname: De Ponti
keywords: erythema; re-epithelialization; rosacea; skin hydration