Mild to Moderate Psoriasis Clinical Trial
Psoriasis is a chronic disorder characterized by erythematous scaly patches which affect the
scalp, trunk, extensor surfaces of the limbs and the genital area. The common form of
psoriasis is referred to as psoriasis vulgaris. There are several variants of psoriasis such
as guttate psoriasis, inverse psoriasis, pustular psoriasis and erythrodermic psoriasis.
Psoriasis is highly prevalent in the general population, mainly as a result of its chronicity
and the absence of a cure. The estimates of psoriasis prevalence are within the range of 0.5%
to 4%.
The diagnosis of psoriasis is made on a clinical base, usually by physical examination,
performed by a dermatologist. Although skin biopsy may be useful in some cases, there is no
laboratory test which may serve as a reference standard to the clinical diagnosis of
psoriasis.
Psoriasis in its mild cases per se is not associated with excess mortality, however, the
disease may affect quality of life of affected patients to a substantial degree. Psoriasis
may be readily apparent to others because of scales and redness of the skin. The skin may
itch and scales may shed from the patients to the environment or directly on other people.
Feelings of stigmatization and major changes in life-style caused by psoriasis have been
documented in numerous studies. The burden of the disease may be exaggerated due to expensive
therapy and complicated therapeutic regimes Patients with mild to moderate psoriasis are
usually treated with topical treatments. Photo-therapy or systemic treatments are reserved to
patients with moderate to severe disease.
Topical corticosteroids may lead to rapid improvement in psoriasis, however rapid relapse
following discontinuation is the common practice leading to chronic use.
Calcipotriene ointment may also be used and requires 8 to 12 weeks of use for maximal effect
and often causes local irritation, particularly when used on the face. The use is limited to
100 gr/week due to hypercalcemia that might follow systemic absorption.
Vitamin A derivative tazarotene may be also be used for plaque psoriasis. Although it can
produce longer remissions than topical steroids, local irritation, cost, and teratogenicity
limit its use.
Coal tar products may be used as steroid-sparing agents, especially useful for enhancing the
efficacy of natural sunlight and phototherapy. Application can be cumbersome because of
irritation, unpleasant smell, brown color that can stain clothing, and propensity to cause
folliculitis.
All of the above treatments are particularly problematic for the face and genital psoriasis
due to the potential side effects and mainly possible severe irritation reducing patients
compliance.
Psirelax is a novel topical medication directed for the treatment of patients with psoriasis.
The formulation of Psirelax includes the following substances: 5%-15% quince seeds jelly,
10%-40% natural base cream (e.g. Ferntree Cottage Pure Base Cream), 55%-75% mixture of
natural anti-oxidants (e.g. Vitamin E, wheat germ oil, Safflower oil), natural skin softening
agents (e.g. sweet almond oil, sesame oil), natural absorption aids (e.g. jojoba oil,
vegetable squalene), natural tissue regenerating and protecting agents (e.g. grape seed oil,
sunflower oil), natural preservatives (e.g. paraben, tea trea essential oil, thyme essential
oil, grapefruit seed extract, Vitamin E) and natural thickening agents (e.g. bee wax,
aloevera, medicinal Vaseline, coconut oil, guar gum, palm oil, borax)
In a preliminary observation, a patient with severe psoriasis applied Psirelax three times
each day during four days. The patient reported complete disappearance of the psoriatic
plaques and pruritus was reduced by 70%. It was suggested to conduct an open study to assess
the effect of Psirelax in patients with psoriasis vulgaris.
The aim of this study is to examine the safety and efficacy of Psirelax in the treatment of
psoriasis.
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