Search | Feedback | Contents | Deutsch
Organ of the

 GD — Society for Dermopharmacy

Issue 2/2006
Issue 1/2006
Issue 2/2005
Issue 1/2005
Issue 1/2004
Issue 2/2003
Issue 1/2003
Issue 2/2002
Issue 1/2002
Issue 4/2001
Issue 3/2001
Issue 2/2001
Issue 1/2001
Issue 1/2000
More Links:
Society for
  Issue 1 (2005)


Treatment of sensitive and poorly curing wounds

Liposomal Povidone-iodine gel providing clinical and economical benefits

In the course of the symposium "Sanitary Economy in Dermatology" organized by the GD department Dermatotherapy on the occasion of 9th GD Annual Meeting in Vienna on 14th and 15th March 2005, Dr. Andrea Schlöbe, Freiburg, presented clinical and pharmaco-economic data relating to topical trauma therapy. In cooperation with Dr. Kerstin Foitzik from the research group of professor Dr. Matthias Augustin at the University Dermatological Clinic Hamburg she had investigated the wound treatment based on a hydro gel containing a hydrosome Povidone-iodine complex.
The medicinal product introduced under the brand Repithel ® as wound therapeutic class III combines the wound healing enhancing function of a hydro gel with the antiseptic properties of liposomal iodine according to the explanation of Schlöbe. It aims at a wide-spread field of applications for which there are already numerous therapeutics available in the market. According to the estimation of Schlöbe 50 to 60 percent of all wounds are characterized as problematic wounds as they only heal poorly or retarded.

Humid wound healing

The therapeutic agents available to date entail the development of resistance towards antibiotics and inhibition of the wound healing by means of antiseptically effective colorants as essential problems. A new product has to come up to this challenge. .

A particular problem arises in this context from the concept of the humid wound healing.
A humid milieu in the wound should be strived for as it stimulates the cell growth and accelerates the healing but it also creates good growth conditions for bacteria and therefore requires an infection prophylaxis

Hydro gel and hydrosomes

This problem is to be solved by means of the hydro gel on the basis of a hydrosome-Povidone-iodine complex. Particular liposomes are designated as hydrosomes which are structured bulbous-like from different layers of phospholipids between which there are large quantities of water with Povidone iodine contained therein in each case.

Owing to the fact that the surface of hydrosomes possesses a high affinity towards micro-organism, the iodine is directly transported to them and is able to take direct effect. The fact that this theoretic concept is also successful clinically could be proven in a study by P. M. Vogt, Hannover. In this context less rejection reactions of transplants could be observed. This is an indication for improved healing and reduced hazard of infection.

Clinic and economy
The investigation of Foitzik and Schlöbe is composed of two parts. Firstly, the status of data as to the clinical effectiveness of the considered preparation has been determined by means of a literature analysis. Thereby it was shown that the efficacy at acute and chronical wounds has been documented by means of several controlled clinical studies. Moreover, it has been reported casuistic about reduced infections and irritations at Ulcus cruris venosum and successful applications at the facial impetigo, acne vulgaris and super-infected atopical eczema.

In the second part of her investigation she focused her attention on the effectiveness under real conditions ("effectiveness") and the economic assessment in comparison to the applied concepts of wound treatment to date. For this aim the use of the preparation has been evaluated in view of pharmaco-economic aspects by means of a decision-tree model whereas the therapy expenses per healing up served as relevant target figure and costs have been recorded from a perspective of the bodies of remuneration.

In the course of the 9th Annual Meeting of the GD and only few days after her successfully passed examination as medical specialist, Dr. Andrea Schlöbe from University Dermatological Clinic, Freiburg, presented results of clinical and pharmaco-economical studies relating to a hydro gel based on a hydrosome-Povidone-iodine complex applied for a short time.

Clinical study

The economic analysis draws on a mono-centric randomized clinical phase III study involving 167 patients at which a mesh graft transplantation for the coverage of skin defects had been made. The skin defects had been caused by wounds, flap removal for plastic reconstruction, chronical defects after wound debridements or after severe soft parts infections. Examined was the standard treatment by means of fatty gauze (Jelonet) in comparison to the same treatment and additional application of the considered Povidone-iodine gel.

The treatments based on hydro gel evinced significant clinical improvements and were well accepted. Occasionally a burning was reported, there was only minor irritation hazard, one patient developed contact eczema. The economic data were assessed retrospectively to the clinical study. At patients suffering from Ulcus cruris the time of healing up under verum was accelerated, there was a significantly reduced loss of transplants.

Economic assessment

Under cost considerations per case of treatment without taking into account of outcome parameter and consecutive treatment, clearly higher costs resulted for the combination therapy of 180 Euro per case compared with only 18 Euro per case with Jelonet solely.

Different is the situation if also consequential charges are regarded as they are here substantial. Because for Dermatotherapy for a loss of transplant, consecutive costs of 525 Euro and for one day of in-patient treatment approximately 300 Euro are to be reckoned with.

When only considering transplant losses the combined treatment leads to slightly higher costs. If, however, also the hospital costs are included, then the combination is more economical.

The average total costs per case under consideration of the different consecutive costs are then with 2.742 Euro 460 Euro below the costs of 3,202 Euro for the standard therapy without the additional application of hydro gel. The reliableness of results has been ensured by sensibility analyses.

This economic assessment relates only to the special application at transplanted wounds. However, the regarded hydro gel is to be considered all in all as interesting therapy option for wound treatment according to the conclusion by Schlöbe. tmb

Survey regarding prescription bases: increased transparency for physicians and pharmacists

Pharmacists are obliged according to Arzneimittelgesetz (§ 55 AMG) (German Pharmaceuticals Act) and Apothekenbetriebsordnung (§§ 6 und 11 ApBetrO) (Pharmacist Operation Procedure) to back up the required pharmaceutical quality of the starting materials at medical prescriptions. In case this should not be feasible, the drug production is not allowed.

Complications concerning this stipulation may appear if the basic principles for dermatological prescription are ordered which represent cosmetics in a juridical sense. Such brand bases are only authorized to be processed in prescription drugs if they have been produced not only according to the standards of the Kosmetik-Verordnung ("Kosmetik-GMP") (Cosmetics-GMP [Good Manufacturing Practice]) but also according to the pharmaceutical stipulations ("Arzneimittel-GMP") (Drug GMP).

Owing to the fact that this formal background is often not obvious for physicians and pharmacists, the Pharmazeutische Laboratorium of the Neue Rezeptur-Formularium (NRF) (Pharmaceutical Laboratory of the New Prescription Formulatory) in cooperation with the GD Gesellschaft für Dermopharmazie has undertaken a survey comprising altogether 20 producer firms concerned in autumn 2004. Involved in the survey were more than 50 brand bases which are prescribed by physicians as prescription bases according to the knowledge of the NRW.

The survey results can be gathered from the report "Transparenz bei Dermatika-Grundlagen" (Transparency at Dermatic Bases) published in original in the Pharmazeutische Zeitung (150 [2005] 588-589 (Pharmaceutical Journal) and section service, page124) by Rosemarie Eifler-Bollen and Dr. Holger Reimann. As service for the readers of DermoTopics, this report has also been published in this issue with the consent of the Govi publishing house.


July 2005 Copyright © 2000 - 2014 Institute for Dermopharmacy GmbH. Contact: