A medical device is typically a product that works on or inside the human body, either temporary or permanent, and is aiming at prevention, diagnosis, monitoring or treatment of diseases.
The key difference versus traditional medicines is that a medical device primarily works mechanically as opposed to pharmacologically, i.e. it works alongside or with your body versus affecting the chemistry of the human cells.
Nowadays medical devices are used for alleviating and treating many severe and chronic diseases of heart, brain, bladder, digestive tract etc. with a superior efficacy to traditional therapy with chemical molecules. This because they typically work directly where your body needs help.
The Dermalex Repair products are effective in result and safe in use. The product range has been awarded a CE mark following assessment by the Notified Body TüV Rheinland. This certifies that the Dermalex product range conforms to all relevant aspects of the Medical Device Directive (93/42/EEC). Clinical evaluation, microbiological & stability testing and safety levels of manufacturer have been complied with. Finally, after conducting a risk analysis it can be concluded that all risks identified are considered negligible and thus further ensuring safety of the product. The products do not contain Corticosteroids, Calcineurin-inhibitors, artificial colouring and parabens.
There exist five types:
Psoriasis vulgaris (plaque), guttate, inverse, pustular and erythrodermic psoriasis of which Psoriasis vulgaris is the most common form (80% of all sufferers)
Psoriasis appears in a variety of forms with distinct characteristics. Typically, an individual has only one type of psoriasis at a time. Generally, one type of psoriasis will clear and another form of psoriasis will appear in response to a trigger.
Plaque psoriasis (psoriasis vulgaris) is the most prevalent form of the disease. About 80 percent of those who have psoriasis have this type. Psoriasis vulgaris is characterized by raised inflamed, red lesions covered by a silvery white scale (dead skin cells). It is typically found on the elbows, knees, scalp and the lower back. Dermalex Repair psoriasis cream usage, as self medication, is advised for treatment of this form psoriasis. In other psoriasis forms symptom management by Dermatologist is necessary (he/she may advice treatment combinations with Dermalex Repair Psoriasis Cream and other topical /systematic drugs, and Light therapy).
Guttate psoriasis is a form of psoriasis that often starts in childhood or young adulthood. The word guttate is from the Latin word meaning “drop.” This form of psoriasis appears as small, red, individual spots on the skin. Guttate lesions usually appear on the trunk and limbs. These spots are not usually as thick as plaque lesions.
Guttate psoriasis often comes on quite suddenly. A variety of conditions can bring on an attack of guttate psoriasis, including upper respiratory infections, streptococcal throat infections (strep throat), tonsillitis, stress, injury to the skin and the administration of certain drugs including (some) anti-malaria drugs and beta-blockers.
Inverse psoriasis is found in the armpits, groin, under the breasts, and in other skin folds around the genitals and the buttocks. This type of psoriasis appears as bright-red lesions that are smooth and shiny. Inverse psoriasis is subject to irritation from rubbing and sweating because of its location in skin folds and tender areas. It can be more troublesome with overweight people and those with deep skin folds.
Primarily seen in adults, pustular psoriasis is characterized by white blisters of noninfectious pus (consisting of white blood cells) surrounded by red skin. There are three types of pustular psoriasis. Pustular psoriasis may be localized to certain areas of the body, such as the hands and feet, or covering most of the body. It begins with the reddening of the skin followed by formation of pustules and scaling.
Pustular psoriasis may be triggered by internal medications, irritating topical agents, overexposure to UV light, pregnancy, systemic steroids, infections, stress and sudden withdrawal of systemic medications or potent topical steroids.
Erythrodermic psoriasis is a particularly inflammatory form of psoriasis that affects most of the body surface. It may occur in association with von Zumbusch pustular psoriasis. It is characterized by periodic widespread, fiery redness of the skin and the shedding of scales in sheets, rather than smaller flakes. The reddening and shedding of the skin are often accompanied by severe itching and pain, heart rate increase and fluctuating body temperature.
People experiencing the symptoms of erythrodermic psoriasis flare should go see a doctor immediately. Erythrodermic psoriasis causes protein and fluid loss that can lead to severe illness. The condition may also bring on infection, pneumonia and congestive heart failure. People with severe cases of this condition often require hospitalization.
Known triggers of erythrodermic psoriasis include the abrupt withdrawal of a systemic psoriasis treatment including cortisone; allergic reaction to a drug resulting in the Koebner response; severe sunburns; infection; and medications such as lithium, anti-malarial drugs; and strong coal tar products.
Psoriasis cannot be cured. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.
While the actual cause of psoriasis is unknown, it is believed to result from genes that influence the immune response in the skin, in which it is inadvertently directed against the body’s own cells.
Researchers believe it results from inflammation and excessive skin cell production. In particular, T-cells, which are a type of white blood cells that aid the normal immune response, are activated unnecessarily.
The T-cells are activated by Langerhans’ cells – present in the upper layer of the skin as a first line of defense of the immune system – to such an extent that they influence a series of reactions that cause and maintain the inflammation while accelerating proliferation of skin cells.
Skin cells normally take about a month to develop, mature, and move to the skin’s surface, where they are continually shed
With Psoriasis, the skin cells mature in less than a week and move to the surface, where they accumulate, resulting in the formation of scales among the red, inflamed tissues.
It causes damage to the skin’s barrier making the skin more susceptible for exterior insults that trigger the inflammation further
- Symptoms range in severity from barely noticeable to outbreaks of lesions that cover most of the body.
- More than half of the cases are mild, covering less than 3 percent of the body, with fewer moderate cases1.
- It appears as raised red patches covered with a silvery white buildup of dead skin cells, called scaling. Other typical symptoms are itching, redness, hardened and enduring dry skin
- Found predominantly on the scalp, face, back, elbows, palms, legs, knees, and soles of the feet
- Scratching due to itching worsens the symptoms and thus again the itching, resulting in a viscous itch-scratch-inflammation cycle.
Itch -> scratch -> damaged skin -> inflammation -> Itch
Literature distinguishes: winter, summer and non seasonally defined Psoriasis. Changes in weather condition, dry air, wet air, changing cold-warm air. Winter depression/sun light deficiency all are said to have a substantial influence on the duration, frequency and the severity of the symptoms. In cold weather, lack of sunshine, when humidity drops in heated and air-conditioned homes and houses and throat infections thrive, Psoriasis tend to flair-up. Also psychological stress tends to have a negative effect.
Dermalex Psoriasis can be used from 14 years of age and older.
Not for guttata and pustular Psoriasis.
No. The product is an oil in water based product which easily washes off, during showering or washing.
The cream has the natural color of its ingredients; no color and smell adjustment is used. The aim is to achieve therapeutic effect through the least harmless composition. The cream, after application does not leave any mark or color on the skin.
No lasting side effects have been recorded during the clinical studies. No allergic reactions or adverse effects have been reported during or after the clinical observation of this product. No contra-indications and/or cross-allergies have been reported during and/or after the clinical observation of this product. Dermalex causes no thinning of the skin, easy bruising or photo allergic reactions.
A preventable/avoidable slight burning sensation might occur (upon the start of the Dermalex Psoriasis Cream treatment caused by a high presence of alkali earth minerals) and it is advised to apply the cream on a wet or damp skin surface. In case of a burning sensation, a dilution with 4-5 times water quantity – in comparison to the cream – will prevent this inconvenience). This sensation when experienced mostly disappears after 3 to 4 day. No other side effects have been recorded.
Avoid contact with eyes and genitals. In case of contact, rinse thoroughly with lukewarm water.
In the case Dermalex Repair Psoriasis cream is combined with other methods of treatment, (in order to reduce side-effects of these methods of treatment or to stimulate the effectiveness of the therapy) it is strongly recommended to consult your physician, dermatologist or pharmacist before starting the Dermalex Repair Psoriasis cream treatment.
Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis (it is considered to be the golden measurement standard). PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
At the beginning of the test period, the symptoms and occurrence will be measured on the body of the patient and translated into a percentage (will be named PASI X). At the end of the same test period, the same is being done (PASI X).