Issuu on Google+

CLINICAL STUDY REPORT Efficacy of Psorioderm® cream in treatment of mild to moderate plaque psoriasis which does not require biological therapy SUMMARY Principal investigator: Eva Remenyik, M.D., D.Sci., Head of the Department of Dermatology, University of Debrecen Medical and Health Science Centre Ethical considerations: The investigational product is cosmetics. Despite, this study was conducted in accordance with GCP (Good Clinical Practice) guidelines. (Number of Ethics Committe approval: OSTRAT/9714/2010) Objective: To assess the efficacy and safety of Psorioderm® cream partly by placebo-controlled, double-blind, parallel-group, comparative study and by continuous routine application of Psorioderm® cream in subjects with mild to moderate plaque psoriasis.

SUMMARY OF PERIOD I, II: I. In the double-blind study, PSI (Psoriasis Severity Index) score decreased significantly and continuously by Visit 8 by the treatment both with placebo and also with Psorioderm® cream with active ingredient. Application of Psorioderm® cream led to greater change in PSI compared to placebo. Assessment of VAS (Visual Analog Scale), demonstrating subjects’ subjective opinion, decreased significantly. Regarding to the assessment of PGA (Physician’s Global Assessment), according to the investigators’ assessment, there was no detectable difference between the results of Visit 1 and Visit 2. However, PGA decreased significantly at Visit 8. Overall, daily used Psorioderm® cream, can alleviate the psoriatic symptoms. Furthermore, Psorioderm® cream may reduce the requirements (application frequency) therefore the side effects of topical steroids, which are the most commonly used agents in psoriasis. II. Based on the results of Period II, treatment with routine application of Psorioderm® (with active ingredient) on the whole surface of the skin, all parameter which indicates the improvement of psoriatic patients’ conditions improved significantly.

APPLIED TREATMENTS Period I.: Double blind, placebo-controlled study • Active ingredient: Psorioderm® cream (Aqua Destillata, Propylene Glycol, Isopropyl Myristate, Hydrogenated Shea butter, Aloe Barbadensis Leaf Juice, Glycerin, Urea, Ribes Nigrum Seed Oil, Borago Officinalis Seed Oil, Polyglyceryl-3 Methylglucose Distearate, Cetearyl Alcohol, Stearic Acid, Cocos Nucifera, Olea Europaea Fruit Oil, Panthenol, Theobroma Cacao Seed Butter, Lanolin, Hydrogenated Wheat Germ Oil, Persea Gratissima Oil, Dead Sea Salt, Dimethicone, Caprylyl Glycol, Salicylic Acid, Tocopheryl Acetate, Calendula Officinalis, PEG-8, Lavandula Angustifolia Oil, Perfume Bianco, Bisabolol, Avena Sativa Straw Extract, Glyceryl Polyacrylate, Zeolite, Butylhydroxytoluol, Caprylyl Glycol, Lactic Acid) • Placebo: The vehicle of Psorioderm® cream (containing moisturizing skin care products) Period II.: All subjects apply investigational products with active ingredient (Psorioderm® shower gel, Psorioderm® lotion, Psorioderm® cream) to treat their psoriatic plaques every day PERIOD I.: Method: Placebo-controlled, double-blind study Duration of study: 10 March 2011 - 10 June 2011 Number of analyzed subjects: 29 subjects Diagnosis: mild to moderate plaque psoriasis which does not require biological therapy Duration of treatment: 6 weeks Method To assess the efficacy, PSI was determined every week. PSI, influenced by the extent of exfoliation, skin inflammation and thickness, indicates objectively the severity of the disease (maximum: 24 points) on the analyzed psoriatic area. At Visit 1, Visit 2 and Visit 8 VAS and PGA were determined. These parameters indicate the subjects’ and the physicians’ subjective opinion on the course of the disease. Treatment - Results In the study, 29 subjects were enrolled of which 27 subjects completed Period I. The mean duration of psoriasis was 22.9 years. On the affected skin of subjects, two symmetric areas (approximately 8x15 cm) were analyzed. There had to be a large or several smaller psoriatic plaques on the observed area. Each of their size had to be at least 10 cm2 and they also had to be localized far from each other. On the enrolment, there was no significant difference between PSI scores of Area 1 (treated with Psorioderm® cream, mean PSI: 15.2, median: 14.00) and Area 2 (treated with placebo, mean PSI: 15.2, median: 12.00) (Figure 3). At the baseline the mean and the median of VAS scores were 5.52 and 5.00, the mean and the median of PGA scores were 3.86 and 4.00, respectively. Compliance was evaluated by a scale range from 1 to 5 at the end of the study. The subjects agreed to neither sunbathe, nor use tanning devices, nor apply other topical creams with active ingredient during the study. Products are available in pharmacies and Eventuspharma webshop. Produced by Pezomed Kft. 4400 Nyíregyháza, Dózsa György u. 60. +36-42-402-008 psorioderm@pezomed.com • www.psorioderm.com • www.eventuspharma.hu


Application of Psorioderm® cream (Cream 1) leaded to greater change in PSI compare to placebo (Cream 2). Assessment of VAS decreased significantly (p = 0.001) (Figure 4). Regarding to the assessment of PGA, there was no detectable difference between the results of Visit 1 and Visit 2, however, it decreased significantly (p = 0.0001) at Visit 8 (Figure 5). According to the investigators’ assessment, the subjects’ symptoms tend to decrease on PGA scores (Figure 5 - above) and they experienced significant improvement, as well (VAS) (Figure 4). Figure 1.

Figure 2.

Figure 4.

Figure 5.

Treatment with Psorioderm® cream caused more significant changes compared with placebo, however, considerable placebo effect was also revealed. SUMMARY - CONCLUSION: Overall, Psorioderm cream using twice daily, can alleviate the psoriatic symptoms. Furthermore, Psorioderm cream may reduce the requirements (application frequency) therefore the side effects of topical steroids, which are the most commonly used agents in psoriasis. PERIOD II.: All subjects apply investigational products with active ingredient (Psorioderm® shower gel, Psorioderm® lotion, Psorioderm® cream) to treat routinely their psoriatic plaques every day. Duration of study: 28 April 2011 (data of the enrolment of the first subject) - 29 August 2011 Number of analyzed subjects: 22 subjects from Period I Diagnosis: mild to moderate plaque psoriasis which does not require biological therapy Duration of treatment: 12 weeks Method: To assess the efficacy, PSI was determined monthly once more. At Visit 1 and Visit 4 VAS and PGA were determined once again. These parameters indicate the subjects’ and the physicians’ subjective opinion on the course of the disease. DLQI (Dermatology Life Quality Index) was also determined during Period II. Treatment - Results: In Period II, 27 subjects were enrolled of which 22 completed the study. All subjects applied investigational products with active ingredient to treat not only their analyzed psoriatic plaques but the whole body surface. Those subjects who completed Period I were enrolled in Period II. All investigated parameter indicating that the severity of psoriasis improved significantly by the end of the treatment compared with the baseline. VAS score was 3.66 at Visit 1, which decreased significantly (VAS: 2.68, p=0.04) by the end of treatment lasting 3 months Figure 1.

VAS median and quartile at baseline and final visit

Figure 2.

PGA median and quartile at baseline and final visit Box-and-Whisker Plot

Figure 4.

DLQI median and quartile at baseline and final visit Box-and-Whisker Plot

Figure 5.

PASI median and quartile at visits Box-and-Whisker Plot

SUMMARY - CONCLUSION: Based on the results of Period II, treatment with routine application of Psorioderm® (with active ingredient) on the whole surface of the skin all parameter which indicates the improvement of psoriatic patients’ conditions improved significantly. ent Abbreviations : PSI - Psoriasis Severity Index | PGA - Physician’s Global Assessment ality Index VAS - Visual Analog Scale — assessment of subjects | DLQI - Dermatology Life Quality products won Hungarian Q Quality Product

FROM HEAD TO SOLE EVERY DAY! • cream • shower gel • body lotion • shampoo Products are available in pharmacies and Eventuspharma webshop. Produced by Pezomed Kft. 4400 Nyíregyháza, Dózsa György u. 60. +36-42-402-008 psorioderm@pezomed.com • www.psorioderm.com • www.eventuspharma.hu


Psorioderm study