Scientific tests on individuals with the Psoriatic skin Symptoms of Psoriasis Vulgaris

• Dr. Andor Deák. Dermatologist
• Dr. Feleki Attila MD.

Budapest. Hungary.

Introduction:
The following efficacy test report was conducted as a manufacturer conducted field test under the guidance of the above-mentioned physicians during the period of May 2004 and March 2005. Volunteers were randomly selected from a pool of German, Dutch, Swiss and Hungarian individuals. Complete privacy and confidentiality of patients' test data was safeguarded under the relevant Hungarian  'Data protection act' as well as the physician - patient confidentiality regulations.  Volunteers were given the choice to provide personal data or register by initials only.    
 
The objective:
Over the past two years Optoderma®  active ingredients, a result of a proprietary production process, have been tested on various occasions on a small number of test volunteers throughout the EU. In addition a clinical efficacy test was conducted in Switzerland. The following test has been conducted with the aim to establish the overall efficacy level and the possible levels of allergenic reactions in amongst the test population. The significance of the results of a test with a test population with a substantial number of long term, therapy resistant and multiple symptom volunteers would provide valuable information for future developments and applications.

Norms, standards and regulations applicable.
The product and the base used, has been tested following the EU norms and regulations as mentioned in applicable EU cosmetic directives (40/2001.XI.23 EUM order and its modifications of 5/2004(II.10) ESZCSM about safety of cosmetic products). Bacteriological safety has been tested prior to usage at the Hungarian National Health Institute (ANTSZ) under the sample registration number 06250/2004. Documentation, follow-up consultation and data analysis have taken place by in-house and contracted physician.
Toxicity of the active and base ingredients and spore elements are all conform the international INCI listing as well as the listing of the U.S. Food and Drug administration (FDA). Optoderma® active ingredients are of a mineral nature, produced according to a proprietary production method.  The product does not contain any tar and sulfur, steroids, vitamin D3 analogs, keratolytic agents, topical retinoids, artificial or genetically manipulated substances, known allergic agents or artificial coloring and scents.

The test product provided to the volunteers in the trial.
The "Optoderma®  with "Optoderma Minerals" as active ingredient,  consisted  of a hypoallergenic and pH neutral cream base, provided by the manufacturer to each volunteer at no cost. The packaging form was a set of 10 Ml aluminum plastified sachets, with the printed text "Optoderma" "sample- muster" and production date. Each person received 20, 10 Ml sachets with Optoderma® Cellular Memorizer active ingredient containing cream.

Application method:
With the sample products, each volunteer received a P.I.L. (Patient Information Leaflet) containing user instructions and other safety and storage information.  Volunteers were requested to pre-select one or two spots for the application of the test product during the 6 weeks test period. No other ointments and topical products were to be used on the pre selected spots during the test periods. Non of the volunteers used any additional oral medication during the test period. Volunteers were instructed to apply the Optoderma®  cream two times daily on the pre-selected spot(s)for a period of 6 weeks. Also the volunteers were requested to read the questionnaire prior to the start of the first application, and to fill out the questions relevant upon starting. All other questions could be filled out after ending the 6 weeks test. In 3 cases the test was terminated before the 6 weeks test was completed.  
 
The population:
The population has been randomly chosen from a pool of applicants of all ages and sexes diagnosed psoriasis vulgaris by their own physician. Volunteers were approached with the help of small newspaper adds in national publications, or were forwarded by physicians or by volunteers with psoriasis vulgaris, who partook in the test. 
 
Focus areas:
Data processing and analyses of the overall efficacy test results have been done on an N=47 bases (50 volunteers -/-3 drop outs) without discriminating on the bases of test location or age. Special attention has been paid to the analyses of the results (as provided in the volunteer questionnaires submitted after the 6 weeks test period) of the levels and speed of improvement of the 3 main psoriatic symptoms; i.e. (1) itching, (2) desquamation, (3) and irritation. Finally, analyses focused on possible allergic reactions, overall ratings of "Convenience", "Improvement of psoriatic symptoms", "Quality of life" and "desired repeat usage".
 
Method of evaluation:
All applicants for the test have been diagnosed by the volunteer's own physician prior to partaking in the test. Volunteers were asked to fill out a questionnaire upon entering the test, psoriatic medical history and information on the types of used medication and past and current treatments. In addition volunteers have filled out an evaluation questionnaire at the end of their test period. The duration of the test period for each volunteer has been 6 week. The conclusions have been drawn by the independent dermatologist on the basis of the subjective volunteer questionnaires collected over the testing period.  (See conclusion).
 
All trial volunteers have been diagnosed "psoriatic patients" by their own physician. 24 of the trial volunteers were female and 26 male. Average age of the individuals was 40.6 years, with a range between 6 and 83 years old. 
 
19 of the trial volunteers qualified as seasonal or periodical patients. They off and on suffer from psoriatic lesions and flair-ups during certain months or periods of the year, or at time of strong psychological stress during certain periods. 31 trial volunteers qualified as chronicle, suffering from continuous psoriatic lesions throughout the year over a longer period of time.  
 
During the 6 weeks trial, 3 of the 50 trial volunteers dropped out of the test prior to the end of the 6 weeks test period for reasons of: A) long time traveling abroad, B) a perceived allergic reaction after 2 weeks, C) dissatisfaction with the expected results. Therefore overall analyses of the summary of the provided volunteer's evaluation data, took place using the data of those 47 psoriatic volunteers who completed the 6 weeks trial period.
 
Regarding the creation of the categories of the various locations of psoriatic symptoms, 4 of the trial volunteers suffered from psoriatic symptoms under and around the nails and 3 of the trial volunteers suffered from psoriatic symptoms in the joints. With all the volunteers, the test however focused on psoriatic skin symptoms on extremities, torso, or combinations of the latter areas. Optoderma®  has not been developed, nor has it been recommended for the treatment of symptoms under and around the nails and or in the joints.
 
With psoriasis to date being a non-curable disease, often those suffering from psoriasis, experience well underestimated discomforting symptoms for long periods of time. Flair-ups come and go with the season and circumstances particular to the individual's case. With side effects and inconveniences of the various treatments often being worse than the symptoms of the skin disorder itself, (many of the treatments, therapies) most volunteers go through trying a realm of creams, medications, ointments and therapies, often and unfortunately without consultation of their physician. For some individuals they work for a certain period, and for some they don't. On average the trial volunteers in this test have gone through at least 3 different therapies and (oral) medications, or have tried various ointments, salves and other remedying product in their life as a psoriatic patient. The average number of years the volunteers in this test were diagnosed with psoriasis was 17.5 
 
Results
Upon the start of the 6 weeks test, volunteers were informed about clear and present possibility of experiencing a light burning sensation upon application of the cream. Instructions have been provided on how to reduce this phenomenon in case it occurs.
From the 47 test volunteers, 20 reported a very light burning sensation of no-or just a few seconds. 36 volunteers reported that a slight burning sensation upon application for a time period of 120 seconds or less.  9 volunteers stated to have noticed similar sensations for a period of 5 minutes or less.  2 volunteers felt a continuous light burning sensation throughout the test. Of 3 volunteers the results are not available since they dropped out.

The questionnaire used for the test was designed to find out after how many days or weeks this initial burning sensation (often caused by small open lesions and irritations of the skin) would last during the course of the 6 weeks test. 41 of the test volunteers reported No or just a slight burning sensation during the initial maximum time period ranging from 0 to 3 days, after the third day this sensation had disappeared. 4 test volunteers reported that it took 7 days before the burning sensation disappeared upon application, and 2 volunteers reported that it took 14 days before the skin became insensitive to the burning sensation.
 
Two (2) volunteers reported what they believed was an allergic reaction in the form of a rash. Although the allergies could not be diagnosed by a physician, one volunteer was recommended to discontinue the test after two weeks, the other finished the 6 week test without any further problem.
Remarkable results were registered with 38 volunteers (81%) who claimed that itching of the psoriatic lesions had reduced or had disappeared as a whole within 3 to 5 days after starting to apply the provided Optoderma®  Cream.

Regarding the visually noticeable reduction of skin desquamation 40 test volunteers (85% of the valid 47 test volunteers) reported such reduction within 2 to maximum 3 weeks after the start of trial. Cumulatively, the total test population of 47 reported a start of the visually noticeable reduction of desquamation at least within 28 days.

A total of 33 test volunteers (70%) reported an overall disappearance and/or drastic reduction of visually noticeable desquamation of the skin. 8 volunteers reported some changes. With 6 volunteers the cream seems to have had NO real or lasting effect on their desquamation.

Disappearance of irritation and redness of the lesions and the skin areas surrounding the psoriatic patches was reported by 30 out of 47 of the test volunteers (64%) within a 3 weeks period. 15 volunteers noticed a reduction or lessening of the skin irritation more later in the test period, ranging from 28 to 42 days after the start of the application. With 2 volunteers no improvement or changes have been noticed at all.

To the question to rate convenience of application and use of the Optoderma®  Cream, using a scale of 1 to 10, (with steps of 0.5) the average score of 47 trial volunteers was a clear and convincing 8.3.
Rating the overall effect on the psoriatic skin symptoms, the 47 volunteers rated the product with clear positive score of 7.8 out of 10.

Overall perceived "Quality of life" having used Optoderma®  for 6 weeks, improved with all the 47 trial volunteers, with the product receiving an overall satisfaction rating of 8 out of 10.

Asked if the volunteers, based on their individual experience and result, would continue the use of the Optoderma®  Cream, 39 of the 47 volunteers (83%) answered with "YES". 6 volunteers stated "NO" and 2 volunteers answered "DON'T KNOW ".

Summary
The efficacy test of the Optoderma®  skin care product shows remarkable results in the reduction of the main psoriatic skin symptoms. 38 out of 47 volunteers reported disappearance or drastic reduction of itching in some few days after start of the application (81%). Cumulatively, 41 out of 47 volunteers reported a reduction or disappearance of visually noticeable desquamation (87%). 45 out of 47 volunteers reported reduction or disappearance of plaque irritation (95%). Taking into account the rated overall "increase of quality of life" (overall rating of 8.0 out of 10) and a perceived overall convenience level of 8.3 (out of 10) (in comparison to other products with the same objective) Optoderma®  can be described as a remarkably promising product.

Following the evaluation questionnaires it appears that the everyday usage of Optoderma®  is much more convenient than other previously used products for psoriatic symptoms. No significant differences were recorded in the overall rating of the "improvement of life" in the groups of seasonal and chronicle patients with respective scores of 84 and 85 out of 100. The efficacy level reached its maximum between 4-6 weeks after continuous usage.
With 83% of all test volunteers (39 out of 47) indicating a clear appreciation for the product and a wish to continue the usage of it, one might conclude that introducing this product on the market may positively and successfully contribute in the fight against the daily inconveniences of the symptoms of the millions of people suffering from this highly inconvenient skin disorder.

The products will be commercialised under the brand name: Psoramexal® Innovative Skincare (psoriatic skin care) and will be available via internet and in pharmacies in Belgium.