Clinical and instrumental assessment of the effects of a new product based on hydroxypropyl chitosan and potassium azeloyl diglycinate in the management of rosacea

Abstract

SummaryBackgroundRosacea 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.AimTo assess the benefit of topical applications of a new product (P-3075).Patients/MethodsA 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®) 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® and Corneometer® devices, respectively. Clinical signs and symptoms were evaluated on a four-point scale.ResultsThe 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.ConclusionsThe 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.

Noninvasive objective skin measurement methods for rosacea assessment: a systematic review

“…found significantly lower values in facial areas with increased erythema (measured with a skin colour imaging system) compared with areas having normal skin colour, and in severe compared with mild/moderate rosacea . Significant skin hydration increases were seen after successful treatment (moisturizers, topical metronidazole, oral tetracyclines) . In two RCTs where patients with ETR and PPR used creams containing silymarin or glycine/chitosan, the placebo groups using vehicle creams without these ingredients also had significantly higher skin hydration after treatment .…”

“…Significant skin hydration increases were seen after successful treatment (moisturizers, topical metronidazole, oral tetracyclines) . In two RCTs where patients with ETR and PPR used creams containing silymarin or glycine/chitosan, the placebo groups using vehicle creams without these ingredients also had significantly higher skin hydration after treatment . Others noticed no significant changes in skin hydration, while rosacea severity decreased after treatment (various topical agents, photodynamic therapy) …”

Treatment of symptoms of erythemato-telangiectatic rosacea with topical potassium azeloyl diglycinate and hydroxypropyl chitosan: Results of a sponsor-free, multicenter, open study

“…Furthermore, a pilot, multicenter, randomized, double blind, and placebo-controlled study confirmed the efficacy of this fixed combination in erythema and dryness in patients with subtypes I and II rosacea, using both the Mexameter Õ and Corneometer Õ devices (5).…”

“…It is obtained by reacting the chloride of azelaic acid with two molecules of glycine and one molecule of potassium hydroxide (3)(4)(5). Azeloglycine, like azelaic acid, has sebostatic and whitening action (3); furthermore, it possesses, thanks to the presence of glycine, a moisturizing effect (3)(4)(5).…”

“…Hydroxypropyl chitosan is a water soluble, semi-synthetic derivative of chitosan that, thanks to its adhesive properties, provides a protective film on the stratum corneum, with a barrierlike action (4,5). In vitro antimicrobial activities of hydroxypropyl chitosan and its derivatives were evaluated by the Kirby-Bauer disc diffusion method and the macrotube dilution broth method.…”