ABOUT ZYMBILAN® WITH RETILEX®-A-PRO AND VERCILEX®-F

What is Zymbilan®?

Zymbilan® is a dual action epidermal rebalancing therapy that works both topically through Zymbilan®-PSO active care skin cream and systemically through Zymbilan®-PRT active care supplement to treat the symptoms of psoriasis.

Its proprietary ingredients include:

  • RetileX-A®-PRO which is a novel, next-generation retinoid.
    RetileX-A®-PRO is developed nano-encapsulation technology that enhances the efficacy of topical retinoids in treating psoriasis. This special encapsulation enhances the bioavailability of retinoids exactly where they are needed, deeper in the skin. This drastically reduces risks like skin redness and burning that are normally associated with other commercially available retinoid treatments.
  • Vercilex®-F is a scientifically formulated natural bioactive complex rich in the specific proteoglycans involved in both reviving the normal turnover of the skin’s extracellular components and rebalancing the skin’s cell growth. Bioactive proteoglycans found in Vercilex®-F possess unique anti-inflammatory properties which contribute to alleviating the symptoms of psoriasis.
What is Vercilex®-F?

Vercilex®-F is the active ingredient in Zymbilan®-PRT active care food supplement and has been scientifically developed from marine proteoglycans. Taken in tablet form, the proteoglycans present in the tablet help revive the turnover of the skin’s extracellular components and to rebalance several cell growth and differentiation pathways within skin cells. Bioactive proteoglycans found in Vercilex®-F possess unique anti-inflammatory properties which contribute to alleviating the symptoms of psoriasis.

What is RetileX-A®-PRO?

RetileX-A®-PRO is the active ingredient in Zymbilan®-PSO active care skin cream and is a next-generation topical retinoid. It works by penetrating the psoriatic epidermal cells to normalise their proliferation and differentiation by modifying the expression of key genes.

What makes Zymbilan® unique?

Since psoriasis is a chronic disorder that requires long-term treatment, finding a therapeutic approach that minimises side-effects and complications must be taken seriously. This is particularly true for most psoriatic patients who have only localised and intermittent flare ups.

Zymbilan® is an effective, safe, and drug-free treatment that can be utilised for longer periods of time without side effects. This makes it a novel choice as a first-line therapeutic option or to enhance the efficacy of other conventional therapies over extended periods.

The Zymbilan® rebalancing approach is based on more than 30 years of research and development into dermal proteoglycans and targeted topical delivery of retinoids. Using innovative and proprietary technologies developed over decades, Zymbilan® has been meticulously assessed for efficacy and safety in multiple long-term published clinical papers involving thousands of individuals.

How does Zymbilan®-PSO Cream work?

Zymbilan®-PSO Cream contains RetileX-A®-PRO, a next-generation retinoid with an optimised dosage and absorption profile. When applied to the skin, RetileX-A®-PRO works by reactivating retinoid receptors in the supra-basal layers of the epidermis. As documented in genetic analysis, many of the genes which have been dysregulated in psoriasis-affected skin are reversed to normal regulation by retinoids. This diverse molecular bioactivity forms the basis of Zymbilan®-PSO Cream’s multiple pharmacological effects:

  1. Suppressing the uncontrolled proliferation of keratinocytes and acanthosis which lead to thickening of the outermost layer of the skin (stratum corneum).
  2. Normalising the differentiation of keratinocytes and epidermal hyperkeratosis to alleviate psoriatic lesions.
  3. Subsiding inflammatory reactions and cytokine production in psoriatic lesions.
  4. Controlling abnormal blood vessel formation (Neovascularisation).
  5. Possessing anabolic effects on skin proteoglycans and other matrix components to alleviate Epidermal Dysglycania (EDG) in psoriatic lesions.
How Do Zymbilan®-PRT tablets with Vercilex®-F work?

Zymbilan®-PRT Tablets contain Vercilex®-F, a formula particularly rich in marine-derived, skin-specific proteoglycans such as syndecans and versicans. Vercilex®-F rebalances the dysregulated metabolism of proteoglycans in psoriatic lesions through Proteoglycan Replacement Therapy (PRT) which effectively addresses Epidermal Dysglycania (EDG), a root cause of psoriasis. Replenishing the components of the skin matrix is essential in psoriasis therapy because even slight improvements in the skin barrier function can lead to significant clinical benefits.

Proteoglycan Replacement Therapy is an innovative approach to psoriasis treatment and is based on over 30 years of research and clinical experience in successfully treating a range of inflammatory disorders with PRT. Research has shown that Zymbilan®-PRT Tablets treat psoriasis by:

  1. Modulating immune response and reducing inflammation.
  2. Inhibiting the hyperproliferation of keratinocytes.
  3. Treating EDG via rebalancing the turnover of proteoglycans.
  4. Improving the function of epidermal stem cells.
Does one have to take both Zymbilan®-PSO and Zymbilan®-PRT to get results from rebalancing therapy?

Vertilex®-F and RetileX-A®-PRO share several bioactivities and pharmacological targets. When used simultaneously, Zymbilan®-PSO cream and Zymbilan®-PRT tablets exhibit synergistic effects which improve clinical efficacy and treatment results.

The results of this intra- and extra-cellular epidermal dual treatment produces better results in most patients when compared with Zymbilan® monotherapy.

Is Zymbilan® the only product worldwide containing RetileX-A®-PRO and Vercilex®-F?

Yes.

Zymbilan® is the only product worldwide containing RetileX-A®-PRO and Vercilex®-F, both of which are proprietary and protected. Consumers should, therefore, be aware of imitation products that claim to deliver similar therapeutic results in treating psoriasis – these are not the original, clinically-proven components found in Zymbilan®.

Is Zymbilan® available without a prescription?

Yes.

While Zymbilan® is often dispensed on the advice of dermatologists and general practitioners, it is a drug-free product produced using natural ingredients. Both Zymbilan® cream and tablets can be purchased without a prescription at clinics and leading retail pharmacies.

Where can I buy Zymbilan®?

Zymbilan® can be purchased without a prescription at clinics and leading retail pharmacies.

In some pharmacies, Zymbilan® cream with RetileX-A®-PRO and Zymbilan® tablets with VERCILEX®-F may be shelved in separate locations. Be sure to ask your pharmacist for help in finding both products to ensure enhanced treatment results.

ABOUT EPIDERMAL HOMEOSTASIS, RETINOIDS, AND PROTEOGLYCANS

Why is epidermal homeostasis important for skin health?

The skin is a dynamic organ that regenerates itself every 27 days. At its outer layer (the epidermis) the skin is exposed to constant environmental wear and tear. This has spurred the evolution of vigorous homeostatic and repair mechanisms that rebalance and regenerate dead and damaged cells and heal wounds. Although knowledge of the precise mechanisms controlling epidermal stratification, homeostasis and renewal are still unfolding, several molecules crucial for these processes have been identified.

We know, for instance, that human keratinocytes exhibit autonomous proliferation driven by the autocrine secretion of several growth factors, mainly the epidermal growth factor (EGF) family, including amphiregulin and transforming growth factor alfa (TGF-α). Psoriasis manifests when the secretion of these potent growth factors is unbalanced, resulting in dysregulated keratinocyte growth.

What are retinoids and why do they matter?

Retinoids are a class of chemical compounds that comprise different forms of vitamin A (or are chemically related to vitamin A) and they are essential regulators of skin homeostasis. Topical retinoids are often used to treat mild to moderate plaque psoriasis by reducing the formation of patches of raised skin and reducing the thickening of the skin that can make dexterity difficult in everyday activities.

Retinoids are used in cosmetics and medicine for several treatments, primarily due to the way they regulate epithelial cell growth. They have many important and diverse functions throughout the body, including regulation of cell proliferation and differentiation, and they have been proven to be particularly effective in treating certain skin disorders.

They are classed into three generations related to: how easily they convert to retinoic acid (their active form), their safety, and their side effects. Essentially, the stronger retinoids are in the crude form, the more effective they will be, but this also means the more side effects they will display in therapy. These side effects include things like reddening of the skin, increased sensitivity, itchiness, and dryness.

All retinoids in generations one to three are characterised by being extremely sensitive to light, and, in general, the retinol used in most conventional therapies is quickly broken down by light once applied to the skin. This means that a large proportion of the active components are never delivered to the lower skin layers – where the effect is needed.

RetileX-A®-PRO is a proprietary next-generation retinoid, developed through 30 years of research and development and unique to Zymbilan®. Using a novel technology, it envelops each retinoid molecule in a carrier system that allows the molecule to penetrate deeply to the layers of the skin. This ‘envelope’ protects each retinoid molecule from light and oxidation, carrying each molecule directly to the keratinocytes in the skin where molecules are then released and can exert their efficacy.

What are proteoglycans and what do they do?

Proteoglycans (PGs), a family of glycosaminoglycan (GAG) conjugated proteins, are important constituents of human skin connective tissue (dermis) and are essential for maintaining the mechanical strength of the skin.

Skin proteoglycans are highly bioactive and contribute to tissue hydration, resistance and resilience by forming super-molecular structures with matrix proteins. More than 40 biological proteoglycans are expressed in skin tissues, the most abundant being versican, decorin, biglycan, perlecan and syndecan-1.

Proteoglycans also act in structural scaffolding roles which aid the proper alignment of skin collagen and elastic fibres. However, the foremost functional importance of proteoglycans is their ability to sequester and control the availability of growth factors which stimulate and orchestrate the normal turnover of skin cells.

Zymbilan®-PRT with Vercilex®-F is formulated to help restore the diminished concentration and function of bioactive proteoglycans to rebalance the skin and assist in the normal regulation of epidermal homeostasis and morphology for sufferers of psoriasis.

ABOUT SAFETY AND SIDE EFFECTS

Is Zymbilan® approved for use in my country?

Health authorities on all continents recognise Zymbilan®, RetileX-A®-PRO, and Vercilex®-F including the FDA, Anvisa, Cofepris, and EFSA (European Food Safety Authority).

Is Zymbilan® safe to use?

Yes. The safety and side-effect-free tolerability of Zymbilan® has been demonstrated in multiple clinical trials and in leading international clinical and medical journals. Furthermore, health authorities on all continents recognise Zymbilan®, RetileX-A®-PRO and Vercilex®-F – including the FDA, Anvisa, Cofepris and EFSA (European Food Safety Authority).

Users are advised to follow these general precautions:

  • Medicated or abrasive soaps, creams and cleansers, including but not limited to products containing sulphur, resorcinol, salicylic acid, alpha hydroxy acid and glycolic acid may increase the risk of skin irritation if used concomitantly with Zymbilan®-PSO cream. Combining Zymbilan®-PSO cream with topical tazarotene is not recommended.
  • Zymbilan®-PSO dual topical and per oral therapy must not be used in patients with hypersensitivity to any of their ingredients
  • Zymbilan®-PSO cream is not recommended for the treatment of unstable or erythrodermic psoriasis
  • As with any topical product, patients using Zymbilan®-PSO cream should inform their physician before undergoing phototherapy.
  • During the first months of treatment with Zymbilan®-PSO cream, individuals are advised to avoid excessive sun exposure and use sun- screen of at least SPF 15 during exposure
  • Avoid applying Zymbilan®-PSO cream around eyes and on genital organs
  • If any skin reactions connected with the application of Zymbilan®-PSO cream occur and do not subside with decreasing the frequency of use, treatment should be discontinued
  • Zymbilan® tablets with Vercilex®-F should not be taken by people who are allergic to fish.
Are there any side effects from using Zymbilan®?

Side effects are extremely rare but should a skin reaction occur during the application of Zymbilan® cream, decrease the frequency of application. If the problem persists, cease treatment temporarily.

Zymbilan® is an effective treatment for preventing steroid-induced skin atrophy in combination with local corticosteroids and for the long-term maintenance of remission and preventing symptom rebound after induction therapy.

Will Zymbilan® cream cause redness or itching?

Clinical studies have shown that side effects and cutaneous adverse effects are minimal when using Zymbilan®.

The unique nano-encapsulation technology in RetileX-A®-PSO helps eliminate ‘retinoid reaction’ or ‘retinoid burn’, which is characterised by redness, swelling, drying and itching of the skin and can be a common side effect of conventional topical retinoid use.

Zymbilan®-PRT tablets are derived from natural marine sources and no interactions between Zymbilan®-PRT tablets and other medications or supplements have been reported.

Does Zymbilan® interfere with any medication?

There are no known or recorded interactions between Zymbilan® tablets and other supplements and medications, but caution should be exercised when using Zymbilan® cream concomitantly with medicated or abrasive soaps, creams, and cleansers.

Is Zymbilan® suitable for everyone?

Zymbilan®-PSO cream is, as with all other topical products, not recommended for the treatment of unstable or erythrodermic psoriasis but is generally suitable for everyone over the age of seven.

During the first months of treatment with Zymbilan® cream, individuals are advised to avoid excessive sun exposure and use sunscreen of at least SPF 15 during exposure.

If any skin reactions connected with the application of Zymbilan® cream, against all expectations, should occur and do not subside with decreasing the frequency of use, treatment should be temporarily discontinued.

Zymbilan® tablets with Vercilex®-F are produced with fish-derived extracts and should therefore not be taken by people with a fish allergy.

Zymbilan® is entirely based on drug-free ingredients, which are evaluated as safe by food and drug authorities globally. Zymbilan® is gluten-free and, therefore, suitable for coeliacs.

Furthermore, health authorities on all continents recognise Zymbilan®, RetileX-A®-PRO, and Vercilex®-F including the FDA, Anvisa, Cofepris, and EFSA (European Food Safety Authority).

Is Zymbilan® safe and suitable for all types of psoriasis?

Zymbilan®-PSO cream is not recommended for the treatment of unstable or erythrodermic psoriasis but has otherwise been proven to help sufferers of other types of psoriasis, in particular as a first-line monotherapy for mild to moderate psoriasis.

ABOUT DOSAGE AND ADMINISTRATION

How often should I use Zymbilan®?

Zymbilan®-PSO cream with RetileX-A®-PRO

Apply Zymbilan®-PSO cream on psoriatic skin lesions once a day in the evening for the first 2 weeks and then twice a day thereafter (morning and evening).

Wash psoriatic skin lesions with a gentle cleanser before application. Distribute the cream to cover the surface of each lesion and gently pat until absorbed. Allow time between applying Zymbilan®-PSO cream and using other products. The duration of treatment varies depending on the severity and treatment response of the lesions.

Long-term treatment is recommended in patients with a chronic condition.

Zymbilan®-PRT tablets with Vercilex®-F

Take 2-4 tablets per day divided in two daily doses, one in the morning and one in the evening, preferably after food. Treatment should continue until the skin lesions are resolved or as recommended by a healthcare professional. Long-term maintenance therapy to prevent rebound may be considered.

Do Zymbilan®-PRT tablets interfere with any medication?

There are no known interactions between Zymbilan® tablets and other supplements and medications.

What happens if I stop using Zymbilan®?

Psoriasis is a chronic inflammatory condition. Zymbilan® therapy will ensure the inflammatory flare ups are kept at a minimum. Complete discontinuation of the therapy will gradually lead to a build-up of the inflammatory molecules in the body that will eventually cause the typical skin flare ups that are symptomatic of psoriasis. Unlike conventional oral and topical glucocorticoid medication used for short-term psoriatic flare ups, which have adverse effects, Zymbilan® is safe and side-effect-free. It is suitable as a long-term maintenance therapy to prevent the rebound of the condition.

Can I use Zymbilan® for longer periods of time?

Yes.

Both Zymbilan®-PSO cream and Zymbilan®-PRT are indicated for long-term maintenance of psoriasis remission and for preventing symptom rebound after induction therapy. Both can be safely used as a long-term rebalancing therapy.

Will using more than the recommended dosage increase the efficacy of treatment?

No.

The recommended administration and dosage of Zymbilan® has been part of a 30-year research and development effort. During that time, clinical studies have helped define the optimal dosing recommendations and it has been demonstrated that intake of more than the recommended daily dosage, as described on the specific product packaging, provides no significant added benefits.

ABOUT PSORIASIS

What causes psoriasis?

While the exact causes of psoriasis are still unknown, psoriasis affects up to 8.5% of all people.

For centuries, it was regarded as a purely epidermal disorder. In the 1970s, however, a major paradigm shift occurred, following the dramatic success of using T-cell suppressive agents in controlling psoriasis symptoms. This observation – along with several lines of molecular evidence – led to the reclassification of psoriasis as a T-cell-driven disorder in which T-cells begin to attack healthy skin cells by mistake. This causes the deepest layer of skin to produce new skin cells more quickly than usual, triggering the immune system to produce even more T-cells. Thus, psoriatic lesions are the result of an aberrant interplay between skin cells and mediators of the immune system (both innate and adaptive).

Today, psoriasis is recognised as a chronic, complex and multisystem, inflammatory skin disorder with a tendency to wax and wane with flares related to systemic or environmental factors. Symptoms often start between ages 15 and 25 but can start at any age. Men, women, and children of all skin colours can get psoriasis.

Genetic predisposition is a major aetiological factor, suggested by the fact that up to 90% of patients report a positive family history of the disorder. The risk of psoriasis is increased by 2 to 3-fold in monozygotic twins as compared to dizygotic twins.

Is psoriasis curable?

There is currently no cure for psoriasis, but there are several available treatments and therapies, including the use of topical retinoids and Proteoglycan Replacement Therapy to address Epidermal Dysglycania (EDG).

In all cases, the management of psoriasis requires the individualisation of therapy with particular focus on improving the patients’ quality of life, addressing co-morbidities, and preventing complications.

How is psoriasis normally treated?

According to epidemiological studies, around 80% of patients have mild psoriasis that can be sufficiently controlled using topical therapies alone. Moderate to severe psoriasis is typically treated with phototherapy combined with systemic therapy or systemic therapy alone.

Conventional topical therapies include keratolytic agents, anthralin, topical corticosteroids, vitamin D analogues, retinoids and calcineurin inhibitors (pimecrolimus and tacrolimus). Various preparations of corticosteroids are widely used to treat mild to moderate psoriasis specifically in the flexure and genital areas as well. Topical Vitamin D analogues often give cause for concern as first-line therapies, due to their safety and potent epidermal anti-proliferation and pro-differentiation effects. Certain retinoids are also commonly used as mono or add-on therapies in mild to moderate cases. Keratolytics, such as salicylic acid, are used to enhance the penetration of topical medications and phototherapy. Other topical remedies in clinical use are anthralin and coal tar.

Photo and/or chemotherapy represent a mainstay in the treatment of moderate to severe psoriasis. Systemic therapy, including retinoids, cyclosporin, methotrexate and oral steroids, is required in severe psoriasis or in cases that do not respond to topical treatment and phototherapy.

With the discovery of major molecular targets in psoriasis, several biologics are currently under development and clinical testing.

What are the limitations of conventional therapies for psoriasis?

Since psoriasis is a chronic disorder requiring long-term treatment, safety is a major criterion in choosing the treatment of choice in all patients.

The reality is that most of the conventional psoriasis remedies can narrowly be classified as safe. This is a serious issue given that the majority of psoriatic patients have only local and limited affliction which does not justify exposing them to a high risk of treatment side effects or complications.

While being an effective modality, phototherapy, for instance, may cause acute side effects, e.g. erythema, oedema, pruritus and pain, as well as long-term cutaneous side effects such as higher incidence of skin cancer, pigmentary disorders, and photoaging. Therefore, physicians are advised to take precautions in selecting patients and to minimise the radiation dose and duration of therapy.

Extended topical or systemic corticosteroid administration, which often serves as a first-line treatment, produces a wide range of adverse effects. Among the complications of chronic use of topical glucocorticoids are localised development of telangiectasias, skin atrophy, hypopigmentation and impaired wound healing resulting from fibroblast function and re-epithelialisation inhibition. Consequently, the metabolism of proteoglycans and collagens is extensively affected by these medications. Studies have disclosed that corticosteroids not only reduce the quantity of various proteoglycans but also alter their distribution and molecular structure, which leads to Epidermal Dysglycania (EDG). On the other hand, tachyphylaxis during treatment and/or rebound after discontinuation can occur, which undermines the value of steroid therapy in psoriasis.

The use of other psoriasis topical therapeutics entails certain restrictive limitations as well. Anthralin therapy is, in some cases, complicated by irritation at application sites; staining of skin and clothing. Apart from this, anthralin cannot be used in pustular and erythrodermic psoriasis and in patients with unstable and progressive presentations. Tazarotene, a synthetic retinoid, is regarded as a second-line therapy that can be applied to a maximum of 10–20% of the body’s surface area. Safety data for this medication is only available for up to one year of treatment. Irritation of the skin with burning, pruritus and erythema can also limit its use.

Considering all this, finding an effective treatment with a benign side effect profile can be difficult. Zymbilan® is one therapy that can be used for extended periods as a first-line therapeutic option or to enhance the efficacy of other conventional therapies.

What does psoriasis mean for one’s overall quality of life?

Timely diagnosis and treatment are imperative in patients with psoriasis to slow down or even halt the progression of its debilitating and life-threatening complications.

Psoriatic skin lesions are outward presentations of a systemic pathological process that can strike other tissues and organs and can lead to other conditions such as:

  1. Psoriatic arthritis: This type of inflammatory arthritis occurs in up to 30% of patients with psoriasis. Psoriatic arthritis can even precede cutaneous symptoms in some cases and tends to involve peripheral and/or axial joints with a spectrum of severity. This at times is rapidly progressive and debilitating.
  2. Cardiovascular complications: Independently of traditional risk factors, psoriasis is associated with an increased risk of myocardial infarction, stroke, and cardiovascular mortality. The more severe the psoriasis is, the higher the risk of cardiovascular complications.
  3. Metabolic disorders: Psoriasis is an independent risk factor for incident diabetes and insulin resistance with a dose response effect of disease severity. Dyslipidemia and metabolic syndrome are also more prevalent among patients with psoriasis than in the general population.
  4. Skin disorders: In psoriatic patients, superimposed lichen simplex chronicus can be seen on pruritic skin lesions. When seborrheic dermatitis coincides with psoriasis lesions it is referred to as ‘sebopsoriasis’.
  5. Psychological impacts: The aggravating impact of psoriasis on physical and emotional health- related quality of life is comparable to major illnesses such as cancer and diabetes. This predisposes the affected individuals to mood disorders. Prospective studies have shown psoriasis to be associated with higher risk of depression, anxiety, and suicidality. This was highest in patients with a severe form of the disorder. These complications usually improve with successful treatment.