Clinical Efficacy of Optoderma® for the Treatment of Psoriasis Symptoms

• Professor Ben L. Pfeifer, M.D.,Ph.D.
• Professor Marcus Schuermann, M.D.
• Dr. Hans Ogal, M.D.
• Dr. Cesary Winnicki, M.D.

Aeskulap – Hospital Brunnen, Switzerland

Introduction:

Psoriasis is a chronic and non-contagious skin disorder, with a rate of occurrence between 2-4% of the general population. The cause of psoriasis is still unknown; however, it is believed that psoriasis is an immune-mediated, genetic disease with a certain degree of heredity. The condition is associated with an accumulation of skin cells from an abnormal high rate of cell replication. Normal skin cells mature and are shed about every 28 days. In psoriatic skin, the skin cells move rapidly up to the surface of the skin over three to six days. The body can't shed the skin cells fast enough resulting in scaly patches also called "lesions" forming on the skin's surface. Psoriasis lesions can be localized around the elbows, knees, scalp, trunk, and proximal extremities. There are a number of treatments and medications available today. For example: Topical (on surface of the skin) medications, including corticosteroids and anti-inflammatory drugs, photo therapy (treatment with sunlight or artificial ultraviolet light), and systemic medications (oral or injected medications that act on the whole body). None of these treatment options is providing total relief of symptoms, and there is no cure of the disease to date.
Encouraged by patient reports about improvement of their psoriatic skin symptoms after use of Optoderma®  products, we decided to investigate the clinical efficacy of this new product series. The following report summarizes our test results.

Material and Methods:

Optoderma®  was obtained free of charge from Optoderma Kft. of Hungary. The pH neutral crème for this clinical test was provided in 100 ml white plastic tubes without label, containing a hypo-allergenic salve base (ungentum hydrophilicum non-ionicum aquosum) and a proprietary mixture of Optoderma® minerals. The proprietary mineral mixture was tested for bacteriological safety at the Hungarian National Health Institute (ANTSZ) under the sample registration number 06250/2004. Optoderma®  products do not contain any vitamin D3 analogs, keratolytic agents, retinoids, coal, pine tars or steroids. The use of these products in humans is considered safe and there is no expected toxicity. The Optoderma®  crème meets all the EU conform regulations of the Cosmetic Order (40/2001.XI.23 EUM order and its modifications of 5/2004(II.10) ESZCSM about safety of cosmetic products).

The Swiss Federal Health Agency (BAG) had been consulted prior to this clinical study, and there was no objection from the BAG with regard to the clinical test of this new cosmetic skin crème.

Fourteen, mostly long term patients with the clinical diagnosis of psoriasis vulgaris were enrolled into this open label clinical study. The demographic data of these patients are summarized in table 1.

Explanations: Disease category: I = only few patches on extremities or torso; II = many patches on extremities and torso; III = many patches on extremities, torso, scalp; IV = III + nails; V = IV + joints; Prior Therapy: A = antibiotics, C = Corticoids, PU = PUVA; ES = external salves
Patients underwent clinical examination (including photographic sessions of their skin lesions) prior to the study as well as at two, four and six weeks of treatment with Optoderma® . Blood laboratory analysis (complete blood count, erythrocyte sedimentation rate, electrolytes, liver function tests and kidney function tests) as well as urinalysis were performed prior to and at completion of the study. Patients were allowed to continue on their respective medicines and/or external skin treatment for their psoriasis. Optoderma®  was applied three times daily to pre-determined skin lesions according to the use-instructions for the crème by the manufacturer. Follow-up examinations and photography of treated skin lesions was done at 2, 4 and 6 weeks of treatment.
Three patients did not complete the study. Two of these patients felt that treatment with Optoderma®  did not improve their skin symptoms, and therefore they opted to withdraw from the study; one patient withdrew because of a too long travel time from her home to the hospital. Statistical analysis was therefore based on the data of thirteen patients.
The evaluation of clinical efficacy and possible side effects of Optoderma®  was divided in two parts, the subjective evaluation by the patient, and the more objective evaluation by the treating physician. For the subjective evaluation questionnaires had to be filled out by the patients at two, four and six weeks of the study. These questionnaires contained questions related to possible effects and side effects from the use of the crème, as well as two visual analogue scales (VAS) to judge the overall efficacy of the treatment, and to estimate the percent reduction of skin symptoms during the application of the crème. For the objective evaluation by the physician, follow-up examinations and comparisons of the photographic images of the respective skin lesions were used.
Statistical analysis involved comparison of the patients’ subjective VAS numbers and the physicians’ objective data regarding skin lesion size, as well as skin redness, desquamation and irritation. Means, standard deviations and standard error were calculated and significance of changes was determined utilizing T-test.

Results:

Eleven of the fourteen patients enrolled in this study had a long standing history of psoriasis (>10 years). All patients had received various anti-psoriasis therapies prior to entering the study, including systemic medication and topical corticosteroids.  None of these therapies had achieved lasting beneficial effect for these patients.  Since one patient choose to discontinue the study prior to completion due to the long traveling distance.
Subjective evaluation (patient questionnaires):
Ten of thirteen patients evaluated (77%) reported improvement of their skin lesions and/or symptoms during the treatment with Optoderma® . Three patients felt that the treatment with Optoderma®  did not improve their skin symptoms. When asked whether the use of the crème was improving these patients’ quality of life, ten of the thirteen patients answered “YES” (77%). The most striking subjective improvement reported was the reduction of itching. When these patients were asked, whether they would continue the use of the crème, ten of the thirteen patients (77%) answered “YES”. As to side effects, the use of the crème was associated with a slight and brief burning sensation upon application to the skin lesions in about 70% of the patients. This burning sensation did last for about 15-120 seconds upon first application of the crème. With increasing duration of crème use the burning sensation was less and less noticed by the patients, and at six week follow-up only 50% of the patients still reported it. 
Objective evaluation (physician):
Seven of the thirteen study patients (54%) showed objective improvements of their skin symptoms, associated with symptom relief, such as reduced redness and desquamation of the skin areas treated with Optoderma®  (see figures 1-4). In five patients the size of the lesions treated also decreased during the study period. Excluding those patients from the evaluation who did not complete the six week treatment course, the objective rate of improvement was 64% (seven of eleven patients). Improvement was more pronounced towards the end of the study period.

Discussion:

Until today, treatment of psoriasis is purely symptomatic. Presently, there is no curative therapy for this skin disease. Systemic treatments in use only rarely achieve any lasting beneficial effects for patients with psoriasis, and unfortunately, these treatments are often associated with a multitude of short and/or long term side effects. Therefore, it is understandable that patients afflicted with this disease are constantly searching for less toxic and more effective alternative therapies to reduce their skin symptoms. One such alternative seemed to be the topical application of Optoderma® , a crème-based remedy with good empirical evidence of skin symptoms relief in psoriasis. The goal of this clinical study was to evaluate whether a six week course of application of this crème to psoriatic skin lesions would improve disease symptoms and whether such use was associated with any side effects.
We found that a six week application of Optoderma®  on selected skin lesions has resulted in a significant improvement of skin symptoms in more than two thirds of the study patients. This improvement was achieved and maintainable with only a minor side effect noticeable as light burning sensation upon application of the crème. No allergic reactions were registered during the 6 week test.
Comparing Optoderma®  with other topical treatments in these patients resulted in similar efficacy. However, there were several favorable characteristics of the examined product. For example, there seems to be no resistance formation usually seen with cortisone containing creams or ointments that are often used for starting treatment. Further, there is no flare up of psoriasis symptoms on discontinuation of Optoderma® , which also is seen with corticosteroid containing topical treatments. Lastly, with Optoderma®  there are none of the side effects seen with long use or misuse of topical cortisone creams, such as changes in skin color, skin thinning and easy bruising. Compared with the application of tars (purified tars in creams, ointments or gels) or anthralin, which are both effective in psoriasis, Optoderma®  is far less messy or smelly, and much easier and more pleasant to use.

In summary, topical use of Optoderma®  improved symptoms in psoriasis patients in about two thirds of the cases. Patients treated with the test product reported less itching, less desquamation and less skin irritation. A slight burning sensation on the skin upon application of the test product was the only noticeable side effect. These promising results demonstrate effectiveness of Optoderma®  in the treatment of patients with psoriasis. 

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.

Correspondence Address:

Ben L. Pfeifer, M.D.,Ph.D.
Professor and Director of Clinical Research
Aeskulap Hospital
Brunnen
Switzerland