Psoriasis Clinical Results
Psoriasis is a chronic, autoimmune disease that appears on the skin. It occurs when the cells of the immune system inappropriately produce hormone-like signals that speed up the growth cycle of skin cells. Psoriasis is not contagious. There are five types of psoriasis: plaque, guttate, inverse, pustular and erythrodermic. The most common form, plaque psoriasis, appears as raised, red patches or lesions covered with a silvery white buildup of dead skin cells, called scale. Psoriasis can occur on any part of the body.
There are many topical OTC and prescription drugs available for treating the symptoms of psoriasis, but there is no cure for the disease. Of the products available to treat psoriasis, none of the OTC drugs, which contain such FDA approved "drugs" as coal tar, are particularly effective in relieving the itching or reducing the number or severity of plaques. Prescription topical drugs include corticosteroids (clobetasol, betamethasone), vitamin D analogues (e.g. Dovonex), or topical vitamin A derivatives (Tazorec). All are somewhat effective short term, and all have some negative side effects. Oral medications include cyclosporine and methotrexate. Phototherapy is also used to treat mild psoriasis. More recent drugs developed for treating moderate to severe psoriasis include "biologics" which specifically target components of the immune system known to be involved in psorsiasis. These include monoclonal antibodies to block T-cell receptor activation (Amevive) and antibodies that block TNF-alpha, an inflammatory cytokine of the immune system (Enbrel). Although these new "biologic" injectables are effective, they are expensive, and because they are strongly immunosuppressive, they can markedly increase the risk of infection.
Therametics' approach for developing effective technologies for addressing inflammatory skin problems is based on: 1) developing topical rather than systemic treatments so that the therapy is confined to the site of disease and not spread throughout the circulatory system, and 2) developing topical formulations that funciton to "reset" the immune system to a basal state, rather than strongly suppressing its ability to function at all. During Therametics drug screening program, several botanically derived chemical compounds were discovered that can: 1) reduce the production of TNF-alpha by skin and immune cells, and 2) reduce the ability of TNF-alpha to activate target cells. Interestingly, many of these compounds are actually approved food flavoring agents that are found on the EAFUS list (everything added to food, U.S.), and which have been widely used to flavor candies, cakes and ice cream for over 50 years. By identifying naturally occurring compounds that are safe and gentle to the skin, Therametics scientists believe that it is possible to develop topical products that effectively improve skin appearance without increasing the risk of skin infections or other medical problems caused by suppressing the body's immune system.
Therametics has developed a novel topical psoriasis treatment serum that contains Therosol® as well as 2% salicylic acid, the FDA approved OTC drug for psoriasis, Because this silicone based serum is so gentle, it can be applied to severly abraded skin without causing any discomfort. To investigate the efficacy of this silicone based serum on psoriasis, Therametics conducted a small clinical study.The investigator for this clinical investigation was Dr. Zoe Draelos, a highly respected and world-recognized dermatologist. For the study, 20 patients with mild to moderate psoriasis were evaluated for psoriasis using an ordinal 6 point scale. Evaluations were conducted at the start of the study (baseline), at 2 weeks, and at 4 weeks. The results at 4 weeks are shown in the bar graph below. The statistical evaluation of the data was performed using a two-tailed Mann-Whitney test.
After 2 weeks of serum use, the clinical investigator's evaluation showed a statistically significant improvement in erythema (p= 0.016) and scaling (p=0.018) which led to a statistically significant decrease in overall severity (p=0.022). This improvement continued on into week 4 where the investigator found statistically significant improvements in erythema (p=0.008), scaling ( p=0.008), excoriation (p=0.021), induration (p=0.023) and overall improvement (p=0.002). This high degree of statistical significance in such a small population of patients indicates that the topical serum formulation is highly effective in reducing the severity of psoriasis.
The patient evaluation of the serum product was essentially the same as the investigator's assessment. Patient evaluations showed statistically significant improvements in redness (p=0.017), peeling (p=0.007), roughness (p=0.004), itching (p=0.054) and overall severity (p=0.008) in just 4 weeks of use.
Therametics is now developing this serum into an OTC topical product for use in treating psoriasis. The serum will contain 2% salicylic acid in an extremely gentle silicone base which calms the skin, prevents moisture loss, speeds exfoliaton, and reduces the symptoms of psoriasis.