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Randomized Controlled Trial
. 2012 Mar;11(1):37-41.
doi: 10.1111/j.1473-2165.2011.00598.x.

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

Enzo Berardesca  1 , Matilde Iorizzo, Elva Abril, Giancarlo Guglielmini, Maurizio Caserini, Renata Palmieri, Gérald E Piérard
Affiliations
Free PMC article
Randomized Controlled Trial

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

Enzo Berardesca et al. J Cosmet Dermatol. 2012 Mar.
Free PMC article

Abstract

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(®)) 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.

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.

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Figures

Figure 1
Figure 1
Evaluation of erythema by means of Mexameter pre–posttreatment. Least-Squares mean changes from baseline.
Figure 2
Figure 2
Evaluation of hydration by means of Corneometer pre–posttreatment. Least-Squares mean changes from baseline.
Figure 3
Figure 3
Front erythema improvement after 28 days of treatment with P-3075.
Figure 4
Figure 4
Right cheek erythema improvement after 28 days of treatment with P-3075.
See this image and copyright information in PMC

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