[en] Adult ; Anti-Inflammatory Agents/administration & dosage/therapeutic use ; Chi-Square Distribution ; Chitosan/administration & dosage/analogs & derivatives/therapeutic use ; Dermatologic Agents/administration & dosage/therapeutic use ; Double-Blind Method ; Erythema/pathology ; Female ; Glycine/administration & dosage/analogs & derivatives/therapeutic use ; Humans ; Male ; Middle Aged ; Rosacea/drug therapy/pathology/physiopathology ; Skin/pathology/physiopathology ; Young Adult
[en] Background Rosacea is a chronic inflammatory skin disease affecting mostly facial skin. Its origin is multifactorial. Important steps in its treatment are avoidance of any triggering factor and control of skin inflammation. Aim To assess the benefit of topical applications of a new product (P-3075). Patients/Methods A randomized, multicenter, double-blind, placebo-controlled, parallel-group, pilot study was carried out to evaluate the efficacy and tolerability of a cream (P-3075) based on 5% potassium azeloyl diglycinate (PAD, Azeloglicina((R)) ) and 1% hydroxypropyl chitosan (HPCH). Forty-two patients (rosacea stages I and II) were enrolled and randomized, 28 in the P-3075 group and 14 in the placebo group. They were asked to apply the cream twice daily for 4 weeks. The main assessments were the objective quantification of erythema and skin hydration using the Mexameter((R)) and Corneometer((R)) devices, respectively. Clinical signs and symptoms were evaluated on a four-point scale. Results The P-3075 cream applied for 28 days was effective in skin protection by reducing erythema, evaluated both instrumentally and clinically. In addition, the clinical assessments of other symptoms such as flushing, stinging, and burning supported the beneficial effect of the P-3075 cream. Conclusions The anti-inflammatory and moisturizing effects of potassium azeloyl diglycinate combined with the protective properties of HPCH allow the new product to be a good candidate for controlling signs and symptoms of rosacea.