20 June 2016, Volume 30 Issue 2(S3)
    

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  • U Wollina, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 1-7.
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    Psoriasis is a chronic, recurring skin disease affecting 2-4% of the population. Genetic predisposition and precipitating factors play a role in its etiology. The disease can occur in any age or gender group. The most frequently affected areas of the body include scalp, extensor surfaces of the extremities, skin folds and nails. While a number of therapies exist for the treatment of psoriasis with a total resolution of the skin, achieving remission in a high percentage of sufferers, a treatment that results in the maintenance of remission and is free of side effects is still a desirable goal. The aim of the study was to investigate the efficacy and tolerability of Dr Michaels® (Soratinex®) topical product family in psoriasis, in terms of decreasing parakeratosis, inflammation, infiltration and involved area. Seven-hundred-and-twenty-two subjects, mean age 42.3 years (range: 18-68 years) with mild to moderately severe psoriasis, with no other current anti-psoriatic therapy, consisting of 382 males and 340 females, above 18 years of age were included and the observations were subjected to statistical analysis. Triphasic application of Dr Michaels® (Soratinex®) products was employed for 8 weeks, using Cleansing Gel, Scalp & Body Ointment and Skin Conditioner. The treatment proved to be ineffective for 22 patients (3.1%) out of 722. 84 patients (11.6%) had moderate improvement with 26-50% of cleared skin lesions; 102 patients (14.1%) had good improvement with 51-75% of cleared skin lesions; 484 patients (67.0%) experienced outstanding improvement with 76-100% of the cleared skin lesions with 52% of them achieving total resolution. Twelve patients worsened and discontinued treatment; 18 patients discontinued because of non-compliance; 33 patients developed folliculitis as a side effect. Based on the results of this study, the Dr Michaels® (Soratinex®) product family can be successfully applied in mild to moderately severe psoriasis when considering the exclusion criteria.

  • K França, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, F Novotny, M G Roccia, G K Maximov, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 9-14.
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    Psoriasis is a chronic, inflammatory, recurrent, genetically determined dermatitis that affects the skin and joints. Many patients affected by this condition seek alternatives and complementary treatment options such as herbal medicines. In order to establish the safety of these products, trials, according to medical standards should be performed to provide the highest quality of data. The aim of this study was to assess the efficacy and safety of an Australian series of herbal skincare products [Dr. Michaels® (Soratinex®) skin-care products for psoriasis] for the management of stable chronic plaque psoriasis. We studied 142 patients (68 females and 74 males) with mild to moderate, stable, chronic plaque psoriasis and they were randomly assigned to either verum or control group. Exclusion criteria were: severe psoriasis, arthropathic psoriasis, intertriginous psoriasis, palmoplantar psoriasis, use of any antipsoriatic treatment and any medication which could influence or interfere with the course of the disease. Both groups consisted of a cleansing gel, an ointment and an oil blend (skin conditioner), packed in neutral bottles, used twice daily for all lesions except the scalp, for 8 weeks. As control products, we used compositions of well-known neutral ointments and medicinal bathing oil. Assessment, using the Psoriasis Activity Severity Index (PASI) scores, was done before treatment and after 2, 4, 6 and 8 weeks. Patient improvement was determined by the percentage reduction of the PASI scores. Statistical analysis was carried out using the Mann-Whitney-U Test with SPSS for Windows. Our investigation demonstrates that complementary methods can play a role in dermatologic therapy as long as they undergo standardised clinical trials and fulfil the basic requirements such as product safety and quality assurance. This study shows that Dr Michaels (Soratinex®) herbal skin-care products improve mild to moderate stable chronic plaque psoriasis significantly.

  • J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 15-20.
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    Psoriasis is a chronic inflammatory disease with negative impacts both physically and psychologically. It is a common disorder affecting 2-3% of the total world population, in some cases causing changes to the nail and joints as well as skin lesions. The cutaneous manifestations of psoriasis can vary in morphology and severity and therapy should be tailored accordingly. The aim of the study was to investigate the efficacy of Dr Michaels® (Soratinex®) product line in the treatment of psoriatic patients with different age and disease severity. A total number of 270 patients with verified psoriasis, aged 9-60 years old participated in the studies, including 128 children: 23 girls and 105 boys, (all of them selected from the Department of Dermato-allergology of the Russian Pediatric Hospital Clinic, Moscow, and of the 4th Department of Dermatology of the 52nd Moscow City Hospital Clinic). The patients were separated into 3 groups according to the severity of the disease (based on the PASI-index). All the patients have been treated with Dr Michaels® (Soratinex®) products twice daily, as three different forms were available for application: a cleansing gel, an ointment and a conditioner. The severity of the disease and the efficacy of the treatment have been defined with the evaluation of the PASI index of each patient. The obtained results were recorded in a graphic form showing the changes of the PASI-index on days 3, 7, 14, and 21 counted from the start of the trial. Clinical remission was achieved in 147 patients, a significant improvement in 73, partial improvement in 32, while no effect was seen in 12 patients and deterioration in 6. This open trial demonstrated the clinical efficacy of topical application of Dr Michaels ® (Soratinex®) preparation. We observed clinical remissions of psoriasis in adults and in children.

  • M Tirant, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 21-28.
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    Psoriasis is a common chronic inflammatory dermatosis that causes significant distress and morbidity. Approximately 50% of patients with cutaneous psoriasis and 90% of patients with psoriatic arthritis demonstrate nail involvement of their psoriasis. Left untreated, nail psoriasis may progress to debilitating nail disease that leads to not only impairment of function but also on quality of life. We report the case of a 50-year-old male patient with recalcitrant nail dystrophies on the fingers since the age of 40, who responded successfully to Dr. Michaels® product family. The patient had a 35-year history of plaque psoriasis localised on the scalp, ears, groin, limbs, and trunk and with psoriatic arthritis. The nail symptoms consisted of onycholysis, onychomycosis, leukonychia, transverse grooves, nail plate crumbling and paronychia of the periungal skin. This case represents the efficacy and safety of the Dr. Michaels® (Soratinex® and Nailinex®) product family with successful resolution of nail dystrophies and surrounding paronychia with no reported adverse events.

  • M Fioranelli, J Hercogovấ, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 29-34.
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    Psoriasis is generally considered as an autoimmune inflammatory cutaneous-systemic disease, with chronic course and high rate of recurrence, while its high risk of comorbidities affect the patients‘ quality of life significantly. Despite the good therapeutic response, most of the available options show tendency for poor tolerance and high rate of occurrence of side effects. Therefore, the interest of patients and doctors to investigate the possibility of treating psoriasis with natural substances is not surprising. The aim of this study was to investigate the efficacy and safety of the herbal skin-care product Dr Michaels® (Soratinex®) for the management of chronic plaque psoriasis, within a 6 to 8 week treatment course. Thirty patients of both sexes, aged between 24 and 70 years with mild to moderate psoriasis vulgaris were included in this study. The products of Dr Michaels® (Soratinex®) were applied in sequence: cleansing gel, ointment after 3-4 minutes and tonic care (for the fire-smeared ointment) 2 times per day for restorative care and cleansing gel for psoriasis within scalp 3 times a week. The study lasted six weeks. The severity and extent of the lesions were evaluated by PASI score (Psoriasis Area and Severity Index). Based on the obtained result, the products of Dr Michaels® (Soratinex®) have proved to be effective in the treatment of mild and moderate psoriasis vulgaris. In the study group, no improvement was observed in 10% of patients, a slight improvement in 20%, good in 40% and very good in 16.6% of patients.

  • M Tirant, P Anderson, P Bayer, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 35-42.
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    We report the case of a 48-year-old female with chronic atopic eczema who responded successfully to Dr Michaels® (Eczitinex® and Itchinex®) product family. The patient had a 41-year history of atopic eczema and presented with erythematous, excoriated lesions with telangiectasia and scattered purpura (bruising) covering 90% of her body surface area. The patient also regularly suffered blepharitis with red, itchy, watery eyes. The patient was treated with Dr Michaels® (Eczitinex® and Itchinex®) ointment and herbal supplements and presented total resolution of the atopic eczema and underlying inflammation within 6 weeks. This case also suggests that Dr Michaels® (Eczitinex® and Itchinex®) product family is safe and effective, even in cortisone acquired sensitive skin.

  • J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 43-47.
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    Psoriasis is a chronic inflammatory T cell-mediated skin disease, affecting about 2% of Hungarian population. Genetic predisposition as well as environmental triggering factors, and innate immune processes play a role in its etiology. Treatment of psoriasis during the initial stages and first years of disease tend to be conservative and frequently based on topical agents. The aim of this study was to investigate and to describe the efficacy and safety of Dr Michaels® (Soratinex®) skin-care products for the topical treatment of stable chronic plaque psoriasis in a Hungarian population. Two-hundred-and-eight-six (120 female/166 male) patients, aged 10-80 years old (mean age 43 years) with mild to moderate plaque psoriasis had participated in the study. The products, including cleansing gel containing a coal tar solution, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done 2 weeks before treatment, at time 0, and after 2, 4, 6 and 8 weeks. Patient's improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks treatment course, 46 patients had a moderate improvement, with the regression of 25-50% of skin lesions; 77 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 115 patients had an outstanding improvement, with the regression of 76-98.9% of lesions. Only 13 patients did not achieve an improvement of psoriasis. Fifteen patients experienced folliculitis, which resolved after cessation of treatment. Seven patients worsened and discontinued treatment. Thirteen patients dropped out because of non-compliance. Our investigation demonstrates that Dr Michaels® (Soratinex®) products, an Australian treatment, can be used successfully in the treatment of stable chronic plaque psoriasis.

  • U Wollina, M Tirant, P Bayer, M Coburn, M SMITH, B Donnelly, T Kennedy, J Gaibor, M Arora, L Clews, S Walmsley, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 49-54.
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    Acne vulgaris is an epidemic inflammatory skin disease of multi-factorial origin, frequently seen in adolescents and often persisting or occurring through to adulthood. Acne vulgaris is a nearly universal skin disease afflicting 79-95% of the adolescent population in westernized societies and is a significant cause of psychological morbidity in affected patients. Despite the various treatment options available for acne, there is still a need for a safe and effective option. The aim of the study was to investigate the efficacy and tolerability of Dr Michaels® (Zitinex®) product family in the treatment of papulo-pustular acne. 25 patients (17 female/8 male), aged 15-22, with a mild to moderate papulo-pustular acne, localized on the face and on the trunk, were included in this study. None of the patients had used any other kind of treatment in the 3 months prior to commencing this study. All of the patients were treated with Dr Michaels® (Zitinex®) facial exfoliating cleanser, activator formula, a cream, PSC 200 and PSC 900 oral supplements. Application time of Dr Michaels® (Zitinex®) products was 12 weeks. The treatment was been evaluated clinically at 0, 4, 8 and 12 weeks. All of the patients showed an improvement in all parameters of their acne (comedones, papules, pustules, hyperpigmentation and scars). The acne lesions and erythema had mostly resolved. The hyperpigmentation and pitted scarring had significantly reduced also, with the skin appearing smoother. The treatment was well tolerated and no side effects have been described. Our study demonstrates that the Dr Michaels® (Zitinex®) facial exfoliating cleanser, activator formula, cream and oral supplements PSC 200 and PSC 900 are an effective therapeutic option for the treatment of moderately severe acne vulgaris. Moreover, it highlights the safety profile of the Dr Michaels® (Zitinex®) product family in a case of acne compared to traditional first-line treatments.

  • K França, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, P Bayer, M Coburn, M SMITH, B Donnelly, T Kennedy, J Gaibor, M Arora, L Clews, F Novotny, M G Roccia, G K Maximov, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 55-63.
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    Atopic eczema is a chronic relapsing inflammatory skin disorder, characterized clinically by intensely pruritic eczematous skin lesions and a defective epidermal barrier. It affects more than 15% of children and up to 10%of adults, which makes the disease a social health problem still without a challenging treatment. The aim of this study was to evaluate the efficacy and tolerability of Dr Michaels® (Eczitinex®) topical product family in the treatment of atopic dermatitis in children. We studied a group of 30 patients (17 female, 13 male), aged 5 to 13 (mean age: 9), affected by atopic dermatitis since they were newborn. All patients had been unsuccessfully treated with conventional anti-inflammatory therapies and ceased treatment 2 weeks before commencing research. The patients were treated with Dr Michaels® (Eczitinex® and Itchinex®) product family including a moisturising bar, topical ointment and PSC 900 oral herbal formulation. The treatment was evaluated clinically and photographically at 0, 1, 2, 4, 6, 8, 10, 12, and 14 weeks. Twenty-eight patients showed a significant improvement of cutaneous rashes and pruritus on the first week of treatment, with a complete remission at 10-12 weeks. Only two patients, brother and sister respectively, showed a slow response to treatment and reported an increasing itching. Following 14 weeks of treatment with the Dr Michaels® (Eczitinex® and Itchinex®) product family, patients demonstrated complete resolution of their AD. All patients showed a marked improvement in their condition within 3 days of treatment with most of the lesions and symptoms totally resolved within 10 to 12 weeks of treatment with Dr Michaels® (Eczitinex® and Itchinex®) family of products. This clinical report highlights that the Dr Michaels® (Eczitinex® and Itchinex®) product family is a safe and effective treatment option for AD.

  • M Tirant, P Bayer, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 65-72.
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    Lamellar ichthyosis (LI) is a genetically heterogeneous group of disorders of keratinization that are inherited in an autosomal recessive fashion, occurring in approximately 1 in 300,000 live births. The treatment of the large, dark, plate-like scales that characterize the classic manifestation of the disease are still a challenge. The aim of this study was to evaluate the efficacy and tolerability of Dr. Michaels® skin-care products for the management of LI. A multi-centre European prospective study was conducted, including 10 patients (3 female/7 male) with lamellar ichthyosis, aged 38-54 years old (mean age: 46). Each patient had been treated with emollients plus other different systemic therapies, such as corticosteroids, Cyclosporin A or retinoids in the past. All patients were treated with Dr Michaels® product family including both topical and oral herbal supplements. The topical treatments used were the cleansing gel, activator formula and ointment. The oral medications were PSC 200, PSC 400 and PSC 900. Within 3 weeks of initiation of treatment, there were improvements observed on the skin including a reduction in scaling, fissuring, and intensity in erythema and pruritus with thinning of the hyperkeratotic plate. After 12-15 weeks, most of the plates and scales had been removed to reveal a normalised skin colour. Evidence of hair, eyelash and eyebrow growth was observed. There was partial nail resolution with a reduction in subungual hyperkeratosis. No adverse reactions were observed. Our patients showed excellent symptomatic response to treatment within a 14-week period, follow-up by an on-going regular assessment on a quarterly basis. The results show that Dr Michaels® product family is an effective and safe treatment option for LI.

  • J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 73-75.
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    Psoriasis is a chronic inflammatory disease, affecting about 3% of the worldwide population. Although there are many therapeutic options available today for psoriasis, none of them can be considered as the gold standard treatment for maintaining a sustained period of remission. The aim of this study was to investigate whether a maintenance dosage of Michaels® Soratinex® product family is effective in maintaining a symptom-free state for patients in remission. Fifty patients (23 male, 27 female), aged 18-58-years-old (mean age: 38.3), affected by mild to severe plaque psoriasis (mean duration: 29.5), were included in this retrospective study. All of them had completed previous treatment and achieved remission. Twenty-eight had been previously treated with an Australian series of herbal skin-care products (Dr. Michaels® Soratinex® skincare products for psoriasis) and 22 treated with biologics. We evaluated the clinical condition of the member of each group every 4 weeks, for 16 times following remission. Maintenance group continued treatment with Dr Michaels® (Soratinex®). Non-Maintenance group discontinued both forms of treatment. The evaluation was based on the PASI score, assuming that at baseline it was zero. Out of 34 patients who continued treatment with Dr Michaels® (Soratinex®) product family in the Maintenance group (22 previously treated with Dr Michaels and 12 previously treated with Biologic), 26 remained symptom free with baseline PASI of zero. Six patients had a mild flare with a PASI increase of 0-25%. Two patients were in the moderate group with a PASI increase of 26-50% and were initially treated with biologic. Out of 6 patients in Dr Michaels non-maintenance group, 3 patients remained symptom free, 1 had a rebound starting on week 36 and 2 rebounded at week 44. Out of 10 patients who were in the non-maintenance from the biologic group, 6 rebounded at week 12, 2 rebounded at week 16, 1 rebounded at week 24 and 1 rebounded at week 32. In the maintenance group no side effects were described, except for a mild form of folliculitis in 3 patients. Treatment did not have to be discontinued and all 3 patients cleared. Based on the results of this study, Dr. Michaels® (Soratinex®) product family can be safely and successfully applied to maintain a symptom-free state, after patients go into remission following treatment with Dr. Michaels® (Soratinex®) product family or biologics in mild to very severe psoriasis, when considering the exclusion criteria.

  • J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 77-81.
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    As one of the most common dermatologic chronic-recurrent disease, variable therapeutic options are available today for management of psoriasis. Although topical high potency corticosteroids, alone or in association with salicylic acid or vitamin D analogues, are still considered the best treatment, they do not seem to possess the capability for a long-term control of the disease or prevent recurrences, as their side effects are major contraindications for continuative use. The aim of this study was to investigate whether Dr. Michaels® product family is comparable to methylprednisolone aceponate (MPA) as a viable alternative treatment option for the treatment and management of stable chronic plaque psoriasis. Thirty adults (13 male, 17 female, mean age 40 years) with mild to severe stable chronic plaque psoriasis, were included in the study. Patients were advised to treat the lesions of the two sides of their body (left and right) with two different unknown modalities for 8 weeks; the pack of Dr. Michaels® products on the left side (consisting of a cleansing gel, an ointment and a skin conditioner) and a placebo pack on the right side, consisting of a cleansing gel, methylprednisolone ointment and a placebo conditioner. Assessment was done using the Psoriasis Activity Severity Index (PASI) scores before treatment and after 2, 4, 6 and 8 weeks. The results achieved with the Dr. Michaels® (Soratinex®) product family for the treatment of chronic plaque psoriasis were better than the results achieved with methylprednisolone aceponate (MPA), even though quicker resolution was achieved with the steroid with 45% of patients achieving resolution within 8-10 days in comparison to 5-6 weeks in the Dr. Michaels® (Soratinex®) group. Before therapy, the mean PASI score of the LHS in Dr. Michaels® (Soratinex®) group was 13.8±4.1 SD and 14.2±4.2 SD in the RHS methylprednisolone aceponate (MPA) group. After 8 weeks of treatment 62% of the Dr. Michaels® (Soratinex®) group had achieved resolution whilst in the methylprednisolone aceponate (MPA) group, the figure remained at 45%. The mean PASI score after 8 weeks of treatment was calculated and in the LHS Dr. Michaels® (Soratinex®) group it was 2.8±1.6 SD and 6.8±2.4 SD in the RHS methylprednisolone aceponate group. In the RHS -methylprednisolone aceponate (MPA) group, 22% of patients failed to respond to the treatment in comparison to 6% in the LHS Dr. Michaels® (Soratinex®) group. Based on the results of this study, Dr. Michaels® products are a more effective treatment option, with insignificant side effects, compared to local treatment with methylprednisolone aceponate (MPA).

  • U Wollina, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 83-87.
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    Alopecia areata is a highly prevalent organ restricted autoimmune disorder that leads to disfiguring hair loss and is thought to involve a T cell–mediated response to the hair follicle. The treatment of alopecia areata is often problematic and very frustrating, partly due to the unknown aetiology of the condition. The aim of this study was to evaluate the efficacy and tolerability of complementary medicine, Dr. Michaels® product family, in the treatment of alopecia areata. Materials and methods: 40 patients (27 female/13 male), with a mean age of 20.3 years, all of them with 1-3 lesions of stable alopecia areata localized on the scalp were included in this trial. Four patients suffered from Hashimoto thyroiditis, and one had a familial history of LES. Exclusion criteria were the use of any treatment or medication, which may influence or interfere with the course of the disease. All patients were treated with Dr. Michaels® StimOils - applied twice daily (morning and night), Hair Lotion – applied twice daily (morning and night), and oral herbal formulation - PSC 900 2ml twice daily with food for 16 weeks. For each patient, photographs of typical lesions were taken at the beginning, and 4, 8, 12 and 16 weeks follow-up. Patient improvement was determined by the percentage of hair regrowth for each lesion. Results: After 10 weeks of treatment using StimOils, Hair Lotion and PSC 900 from Dr. Michaels® product family, 18 patients had achieved an excellent response with regrowth in all the affected alopecia areata patches. 17 patients achieved the same results after 12 weeks of treatment; the other 5 patients had to continue the therapeutic protocol for another 2-3 weeks. Conclusion: This study demonstrates that the Dr. Michaels® StimOils, Hair Lotion and PSC 900 are an effective therapeutic option for the treatment of alopecia areata. This has important implications for resistant cases of alopecia areata where traditional systemic and topical corticosteroid therapies have failed. In addition, this treatment approach may be an attractive option for patients who have growing concern regarding side-effects of long-term corticosteroid therapy.

  • J Hercogovấ, M Tirant, P Bayer, M Coburn, B Donnelly, T Kennedy, J Gaibor, M Arora, L Clews, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 89-93.
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    Candidal intertrigo is an infection of the skin caused by Candida albicans that typically occurs in opposing cutaneous or muco-cutaneous surfaces. Because Candidiasis requires a damaged and moist environment for infection, it typically occurs in areas of friction such as the skin folds of the body. Candidal intertrigo is often difficult to treat and results are often unsatisfactory. In addition, there is a lack of evidence-based literature supporting prevention and treatments for candidal intertrigo. The aim of the study was to evaluate the efficacy of Dr Michaels® (also branded as Fungatinex®) products in the treatment of fungal intertrigo, in 20 women and 2 men with a mean age of 72. Five patients (3 female and 2 male) had type 2 diabetes and 16 (14 female and 2 male) were obese. The patients were treated with Dr Michaels® (Fungatinex®) moisturising bar, topical ointment (twice daily application) and oral herbal formulation, PSC 200 two tablets twice daily with food. After 2 weeks of treatment, the lesions had mostly resolved in all patients with only slight erythema evident. After six weeks of treatment using the moisturising bar, topical ointment and oral herbal formulations from the Dr Michaels® (Fungatinex®) product family, the lesions had totally resolved in 18 patients, while 4 patients had to continue the therapeutic protocol for another 2 weeks. Our results demonstrate that the Dr Michaels® (Fungatinex®) complementary product family is efficacious in the treatment of recalcitrant candidal intertrigo. Furthermore, this study highlights that the Dr Michaels® (Fungatinex®) product family is fast-acting and well tolerated with no serious adverse events reported. These data have important implications for resistant cases of candidal intertrigo where traditional therapies have failed.

  • M Tirant, P Bayer, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 95-102.
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    Systemic lupus erythematosus (SLE) is a complex autoimmune disease in which the body's immune system mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain and other organs. We report the case of a 7-year-old female patient with facial lesions of SLE since the age of 5. There was no significant family history and patient had been a healthy child from birth. The child presented with a malar rash, also known as a butterfly rash, with distribution over the cheeks but sparing the nasal bridge. This case represents the efficacy of the Dr. Michaels® (Soratinex®) product family in the successful resolution of facial lesions of SLE.

  • U Wollina, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 103-108.
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    Psoriasis is a lifelong chronic inflammatory disease affecting 2-3% of the worldwide population. Scalp psoriasis is a particular form of psoriasis characterized by lesions on the scalp, which may occur isolated or in association with other skin lesions. The aim of this study was to investigate the efficacy and safeness of an innovative treatment of scalp psoriasis, which is based on the topical application of natural products. Fifty adult subjects with scalp psoriasis (23 females, 27 males) from different European dermatological centres were included in the study. Forty-six patients with severely infiltrated psoriatic lesions were invited to use the products of Dr Michaels® (Soratinex®), according to a three-phase application, twice a day (morning and evening). The other 4 patients followed a different regimen: after a shampoo in the evening, they applied the conditioner in the night and washed it in the morning with the cleansing gel. The application time of Dr Michaels® (Soratinex®) products was 8 weeks. The treatment was evaluated at 0, 1, 2, 3, 4, 5, 6, 7, and 8 weeks. The evaluation was based on the Psoriasis Scalp Severity Index (PSSI) and on a photographic analysis at each of the medical evaluation points. At the end of the study, all patients showed an outstanding improvement. Five patients referred a transient pruritus, which regressed spontaneously without discontinuing the application. No other side effects have been described. We observe that Dr Michaels® (Soratinex®) natural product family can be considered as a valid therapeutic tool for scalp psoriasis when considering the exclusion criteria. The tested products provided an outstanding improvement of lesions in all the patients, without side effects.

  • S Gianfaldoni, J Hercogovấ, M Fioranelli, A A Chokoeva, G Tchernev, U Wollina, M Tirant, F Novotny, M G Roccia, G K Maximov, K França, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 109-113.
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    Psoriasis is a chronic inflammatory disease with negative impacts both physically and psychologically. It is a common disorder affecting 2-3% of the total world population, in some cases causing changes to the nail and joints as well as skin lesions. The cutaneous manifestations of psoriasis can vary in morphology and severity and therapy should be tailored accordingly. Even if today many therapeutic options are available for psoriasis treatment, none of them provide excellent clinical results without the risk of side effects. The authors investigate the efficacy of Dr. Michaels® (Soratinex®) natural products in the topical treatments of a group of psoriatic patients. Sixty-two patients (34 male/28 female) from Romania, aged 18-70 years (mean age: 52 years), affected by a mild to severe form of chronic plaque psoriasis were included in this study. Each patient has been treated with a triphasic application of Dr. Michaels® (Soratinex®) natural products, twice a day for six weeks. The products were applied on skin and scalp lesions, but not on the face, genital and flexures. The evaluation of the tested products was based on the PASI of each patient at time 0, 1, 2, 3, 4, 5, and 6 weeks. The tested products were ineffective in five of 57 patients. Eleven patients had a moderate improvement (PASI decrease 26-50%); 11 patients had a good improvement (PASI decrease 51-75%) and 30 patients an outstanding one (PASI decrease 76-100%). Twenty-three% of patients developed folliculitis that regressed upon discontinuation of the application. Five patients developed pruritus, which regressed spontaneously. The cosmetic effect was evaluated as indifferent by 44% of patients, as good by 40% of patients and as excellent by 16% of patients. Ninety-five% of patients stated that they would continue to use the tested products, because it was effective and with poor side effects since the products were natural. In our experimental study, the topical application of Dr. Michaels® (Soratinex®) natural products proved to be an effective natural therapeutic option for psoriasis treatment.

  • K França, F Novotny, J Hercogovấ, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M Tirant, M G Roccia, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 115-119.
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    The aim of the study was to investigate the efficacy and safety of Michaels® (Soratinex®) remedies in patients suffering from chronic plaque psoriasis in a Czech population. Seventy-five (34 female/41 male) patients, aged 18-72 years old (mean age: 38.5 years) with mild to severe plaque psoriasis participated in the study. The products, including cleansing gel, ointment and skin conditioner, containing fruit acid complex, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Histologic variables and various blood picture parameters, including FW, glucose, cholesterol, triacylglyceroles, bilirubin, GMT, ALT, AST, creatinine, uric acid and urea in blood were monitored, before and after therapy with Michaels® (Soratinex®) treatment. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done at time 0, and after 2, 4, 6 and 8 weeks. Patient's improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks using Dr Michaels® (Soratinex®) treatment course, 5 patients had a moderate improvement, with the resolution of 25-50% of skin lesions; 11 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 50 patients had an outstanding improvement, with the regression of 76-100% of lesions. Only 4 patients did not achieve an improvement of psoriasis. Six patients experienced folliculitis, which resolved without cessation of treatment. Three patients worsened and discontinued treatment. Six patients dropped out because of non-compliance. The blood results and histologic findings were all normal. Our investigation shows that Dr Michaels® (Soratinex®) products can be safely and successfully used in the treatment of chronic plaque psoriasis.

  • K França, M Tirant, J Hercogovấ, F Novotny, M Fioranelli, S Gianfaldoni, A A Chokoeva, G Tchernev, U Wollina, M G Roccia, T Lotti
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 121-127.
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    Psoriasis is a chronic inflammatory disease affecting 1-3% of the general population. Due to the chronic nature of the disease, patients suffer from substantial psychosocial impact and impaired quality of life. Dr Michaels® (also branded as Soratinex®), an Australian series of topical herbal products, has been showing promising results for the treatment of patients with chronic plaque psoriasis and consequent improvement in their quality of life. This study aims to access the changes in quality of life of patients with Psoriasis using an Australian series of herbal skin-care products Dr Michaels® (Soratinex®) for psoriasis. The aim of this study is to observe and analyze the impact of Dr Michaels® product family on the quality of life of patients with psoriasis, 566 patients completed the Dermatology Quality of Life Index (DQLI) questionnaire in their initial consultation and at 3 follow up consultations, over a 6 months period. At the end of the data collection, all patients answers were recorded and analyzed. The Psoriasis Area and Severity (PASI) Index were used to measure the severity and extent of psoriasis during the 3 consultations. The PASI for severe, moderate-severe, mild-moderate cases across time revealed a significant effect of the treatment within weeks, confirming the decreasing scores during the treatment. As well as PASI results, the final DLQI score showed a sensible reduction from mean =6.716 (at week 0) to 6.252 (at week 2), 4.015 (at week 6) and 2.407 (at week 10) signifying a 64.2% reduction of the initial score. This study demonstrates that Dr. Michaels® (Soratinex®) products, an Australian series of herbal-based skin products is effective for the treatment of psoriasis. This treatment also significantly improves patients' quality of life.

  • V Barygina, M Becatti, A Mannucci, N Taddei, M Tirant, J Hercogovấ, K França, M Fioranelli, M G Roccia, G Tchernev, U Wollina, T Lotti, C Fiorillo
    Journal of Biological Regulators and Homeostatic Agents. 2016, 30(2(S3)): 129-131.
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    Psoriasis is an inflammatory skin disease that affects 2-5% of the worldwide population. It is a chronic immune-mediated hyperproliferative inflammatory skin disease of unknown etiology, characterized by the appearance of sore patches of thick, red skin with silvery scales.