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

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.

Efficacy of Conventional and Liposomal Povidone-Iodine in Infected Mesh Skin Grafts: An Exploratory Study.

INTRODUCTION: Infection is a major threat to wound healing and a leading cause of graft loss in patients undergoing meshed skin grafts (MSGs). Therefore, topical antisepsis is important in the overall treatment scheme. METHODS: An exploratory satellite group of 14 patients with infected MSGs were enrolled as part of a prospective, randomized, controlled, parallel-group, open-label, pilot Phase II study that investigated the efficacy and tolerability of 3% liposomal povidone-iodine hydrogel (PVP-ILH, Repithel®; RepiGel®) versus chlorhexidine gauze in non-infected MSGs. The satellite group included both patients with infected wound beds prior to grafting and patients with infection of a previously placed graft, with MSG sizes ranging from 50 to 1000 cm2, who were randomized to treatment with (PVP-ILH) or 10% povidone-iodine ointment (Betaisodona®; BETADINE®). Medication was applied in a 2-mm layer and dressing changes with identical application of study medication took place daily. Wounds were evaluated by photoplanimetry, microbiologically and subjectively by patients and physicians. RESULTS: The results for the main study group have been reported previously. In the satellite group, both PVP-ILH and povidone-iodine ointment performed remarkably well with respect to lowering the bacterial count and restoring wound healing, with different emphasis. Povidone-iodine ointment showed excellent antibacterial efficacy with no detectable microorganisms by Day 10, and rapid re-epithelialization (mean 90% by Day 6). PVP-ILH also demonstrated rapid re-epithelialization (mean 72% by Day 6) with a trend towards improved subjective measures of wound healing quality. Four patients (40%) receiving PVP-ILH experienced partial graft loss (10-15% of total MSG area); no patients in the povidone-iodine ointment group experienced graft loss. CONCLUSION: Our results suggest that povidone-iodine ointment has a strong role in managing infected wounds, especially when a high concentration of povidone-iodine may be warranted, while PVP-ILH indicated similar beneficial results on markers of wound healing quality in larger infected wounds. TRIAL REGISTRATION: The trial was conducted prior to mandatory registration of drug products, PVP-ILH represents a medicated device in the EU and many other countries. FUNDING: Mundipharma Research GmbH & Co. KG.

Meeting the challenges of opioid-induced constipation in chronic pain management - a novel approach.

Opioid analgesics are the cornerstone of pain management for moderate-to-severe cancer pain and, increasingly, chronic noncancer pain. Despite proven analgesic efficacy, the use of opioids is commonly associated with frequently dose-limiting constipation that seriously impacts on patients' quality of life. Agents currently used to manage opioid-induced constipation (OIC), such as laxatives, do not address the underlying opioid receptor-mediated cause of constipation and are often ineffective. A significant need therefore exists for more effective treatment options. A novel approach for selectively and locally antagonizing the gastrointestinal effects of opioids involves the coadministration of a mu-opioid receptor antagonist with negligible systemic availability, such as oral naloxone. Combination therapy with prolonged-release (PR) oxycodone plus PR naloxone has been shown to provide effective analgesia while preventing or reducing constipation. The current article highlights this novel strategy in its potential to significantly improve the quality of life of patients suffering from chronic pain, affording patients the benefit of full analgesia, without the burden of OIC.

Efficacy of povidone-iodine vaginal suppositories in the treatment of bacterial vaginosis.

A prospective, randomized clinical trial was performed to study the efficacy of povidone iodine (Betadine) suppositories for the treatment of bacterial vaginosis (BV) in comparison to capsules containing lactobacilli (Döderlein Med). Seventy patients with BV included in the study were randomly assigned to be either treated with povidone iodine suppositories or lactobacilli. Patients were treated once a day for 5 days. Initial examinations took place on the first day of the study with follow-up examinations on days 8 and 15. The examinations included clinical parameters, patient evaluation, secretion screens, and quantitative and qualitative microbiological tests of vaginal flora. Both treatment groups showed improvement of clinical parameters, condition of secretions and subjective state of health. At day 15 there was a trend towards a better efficacy of the treatment with povidone iodine but this was not significant. However, patients with acute BV treated with povidone iodine had significantly better scores after 15 days. Both treatments were well tolerated. The microbiological examinations showed an increase of the mean number of lactobacilli in the vagina on day 8 after initiation of treatment with lactobacilli, but a decrease on day 15. Contrary to that the lactobacilli counts from patients treated with povidone iodine suppositories decreased after the first week but increased in the second one. Potentially pathogenic germs, e.g. Gardnerella, Bacteroides and Enterobacteria were reduced in a higher extent and with a longer lasting effect after treatment with povidone iodine suppositories than with capsules containing lactobacilli. The results of this study show that native lactobacilli rapidly re-colonize after the antiseptic treatment with povidone iodine. Therefore, there is no need to use lactobacilli in addition.