NCT01000714

Determination of the Efficacy and Safety of Psirelax in the Relief of the Disease in Psoriasis

Completed Phase 2 Last updated 22 October 2009

What this trial tests

Phase 2 trial testing Psirelax in Mild to Moderate Psoriasis. Completed.

Quick facts

Lead sponsor	Etwal Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Sites	1 location across Israel

Drugs / interventions tested

• Psirelax — full drug profile →

Conditions studied

• Mild to Moderate Psoriasis — all drugs for Mild to Moderate Psoriasis →

Sponsor

Etwal Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Mild to Moderate Psoriasis.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.