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Why
did we do this test ? Psoriasis is a common worldwide inflammatory skin disease with a frequency of about 2 %. There is a clear genetic disposition although transmission is incomplete. This means that frequently one ore even more generations in an affected family may be spared. Stable chronic plaque psoriasis is the most common manifestation. Patients present with sharply circumscribed red and scaly inflammatory patches (erythematosquamouse plaques) on scalp (fig. 1, 2), elbows (fig. 3), lower back and knees. The nails of fingers and of toes may be a affected too (fig. 4, 5). Very often the patients complain about itching and uncomfortable sensations due to the extreme dryness of the lesions. It could be shown that there are two peaks for the first manifestation of the disease: one between the age of 20 and 40, the second in patients older than 60. However, psoriasis may already present in infancy (fig. 6). The disease may be triggered by several drugs (e.g. beta-receptor blockers), by regular alcohol intake, bacterial infections and by psychological stress. It is common knowledge that the course of the disease shows saisonal-dependent fluctuations (worsening in spring and fall). Actually, the skin lesions are cosmetically very disturbing. A treatment modality which completely cures the disease is not available at present. However, numerous symptomatic therapeutic options are available to improve / clear the skin manifestations. Until now, topical steroids are the mainstay of therapy of mild to moderate psoriasis. As resentment toward steroids is increasing among patients with psoriasis there is urgent need of alternative treatment options.
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Which products were tested ? Recently an Australian series of skin care products (Dr. Michaelsâ skin care products for psoriasis, Melbourne, Australia) which are free of steroids was introduced on the Austrian market. This series consists of a cleansing gel, an aromatherapeutic body ointment and a skin conditioner which are registered as cosmeticals. Except a little amount of coal tar (cleansing gel) the products contain only herbal remedies. At present, however, the therapeutic principle is not known.
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How did we do the test? We compared the efficacy of Dr. Michaelsâ skin care products for psoriasis with a series of fatty compositions. The test was conducted as prospective, double-blind, placebo-controlled, randomized study. We chose this study design because it prevents systemic errors and at present is regarded the gold standard of clinical trials. Prospective study design means that the patients were included in the study population and followed-up for 8 weeks. The assignment of a patient to one of the study groups, either verum or placebo, was done randomly according to a preprepared random list. Neither the clinical investigator nor the patients were informed which product series was handed out to them (double-blind). As placebo products we used common, fatty skin care products, composed of ointment bases which did not contain any active ingredients but were used in the same fashion as Dr.Michaels â skin care products for psoriasis. The cleansing gel was applied generously on the lesions and washed off after three to five minutes. Afterwards the psoriatic plaque was covered with the aromatherapeutic ointment. Finally the plaque was "sealed up" with a thin layer of the skin conditioner. The treatment procedure was done twice daily. The treatment period was 8 weeks. Before, after 2, 4, 6 and 8 weeks we assessed the efficacy by evaluating the PASI (psoriasis area and severity index) score.
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What were the results? We analysed 22 patients who had finished the 8 weeks treatment course. Both groups showed an improvement which was significantly higher in the group with Dr. Michaelsâ skin care products for psoriasis. In the verum group the PASI score improvement was 87 % whereas the improvement in the placebo group was 22 %, respectively. Three patients in the verum group and 2 patients in the placebo group developed mild side effects (folliculitis, irritative dermatitis). In none of the patients it was necessary to discontinue the trial. Figure 1 shows a psoriatic lesion before and after 8 weeks treatment with Dr. Michaels â skin care products for psoriasis (fig. 2).
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Summary
In our clinical trial Dr. Michaels® skin care products for psoriasis showed a significant improvement in patients with light to medium stable chronic plaque psoriasis when compared to placebo. However, you should use Dr. Michaels â skin care products for psoriasis only after consultation with your dermatologist, who can recommend the correct therapy out of the broad spectrum of different treatment modalities.
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