Efficacy and tolerability of liposomal polyvinylpyrrolidone-iodine hydrogel for the localized treatment of chronic infective, inflammatory, dermatoses: an uncontrolled pilot study

Abstract

Infection is common in many chronic, inflammatory skin conditions but is often difficult to treat, in part due to growing bacterial resistance to antibiotics. Liposomal polyvinyl-pyrrolidone (PVP)-iodine hydrogel has a unique mode of action, combining the antiseptic and anti-inflammatory actions of PVP-iodine with the drug delivery and moisturizing properties of liposomes. We investigated the utility of liposomal PVP-iodine to treat infective dermatoses. In this prospective, single-arm (uncontrolled), open-label Phase II pilot study, patients with acne vulgaris (n=30), atopic dermatitis (n=20), impetigo contagiosa (n=10), and rosacea (n=10) received PVP-iodine (3%) hydrogel for ≤4 weeks. Global Clinical Severity score improved for all dermatoses (range: 0.5 for acne vulgaris [p<0.001] to 1.0 for impetigo contagiosa [p=0.011]). Improvements in pain, quality of life, (Freiburg Life Quality Assessment), and Eczema Area and Severity Index scores were also seen. Treatment was well tolerated; most frequent adverse events were burning (14%) or itching (9%) sensations. Thus, liposomal PVP-iodine hydrogel has potential utility as an effective treatment for inflammatory skin conditions associated with bacterial colonization.

Keywords: acne vulgaris; atopic dermatitis; impetigo contagiosa; liposomal PVP-iodine hydrogel; polyvinylpyrrolidone; rosacea.

Figure 1

Disposition of enrolled patients. Notes: Outcomes were analyzed in the intent-to-treat population (N=70) Abbreviation: PVP, polyvinylpyrrolidone.

Figure 2

Change in Global Clinical Severity scores from baseline to end of treatment. Notes: Global Clinical Severity score was the mean score of different clinical symptoms for the skin area treated with study medication and rated on a five-point numerical analog scale (1= not at all to 5= very strongly). Median (range) Global Severity scores at baseline and final visit were: acne vulgaris (2.3 [1.5, 2.8], 1.7 [1.2, 2.8]); atopic dermatitis (2.8 [2.0, 3.7], 2.2 [1.5, 3.2]); impetigo contagiosa (3.2 [2.2, 3.6], 1.8 [1.0, 2.6]); and rosacea (2.9 [2.2, 3.6], 2.1 [01.6, 2.8]). Statistical analysis was performed using Wilcoxon signed-rank test.

Figure 3

Impact of liposomal PVP-iodine (3%) hydrogel on treated skin areas. Notes: Photographs of representative patients with infective dermatoses at baseline and following 1 week and 2 weeks of study treatment. Abbreviation: PVP, polyvinylpyrrolidone.