Silkis

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Silkis

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Silkis

What is Silkis?

Silkis is a topical medication used for the treatment of plaque psoriasis. It contains the active substance calcitriol, which is a derivative of vitamin D.

Mechanism of Action

Psoriasis is characterized by the excessive production of skin cells (keratinocytes) and localized inflammation. Calcitriol works by interacting with specific receptors in the skin to help regulate cell growth. It inhibits the overproduction of these cells and promotes their normal development, which helps to flatten and clear the thickened, scaly patches (plaques) associated with the condition.

Indications and Use

This medication is specifically indicated for the management of mild to moderate plaque psoriasis that affects up to a specific percentage of the body surface area. It is typically applied to the affected areas of the skin to improve the appearance and texture of the lesions.

Characteristics

As a vitamin D analogue, Silkis provides a non-steroidal approach to managing psoriasis symptoms. It is formulated as an ointment to ensure effective absorption into the skin layers where the underlying cell dysfunction occurs. Unlike some other treatments, it is designed for longer-term management of chronic plaque psoriasis rather than immediate, short-term relief.

What side effects are possible with Silkis?

Silkis: Possible Side Effects and Safety Information

Silkis (calcitriol ointment) is primarily associated with local adverse reactions at the application site. The most commonly documented side effects include pruritus (itching), skin discomfort, erythema (redness), and skin irritation. Less common effects include dry skin and psoriasis aggravation.

Systemic Risks and Monitoring

The active ingredient, calcitriol, is a form of vitamin D, and its systemic absorption carries a very rare risk of affecting calcium balance. Hypercalcaemia (high blood calcium levels) is a serious adverse reaction, typically linked to excessive use (above the recommended maximum of 30 grams per day or application to more than 35% of the body surface area) or accidental ingestion. Symptoms of hypercalcaemia may include increased urination, confusion, or nausea.

Monitoring of serum calcium levels is recommended, particularly if risk factors for hypercalcaemia are present. If elevations occur, treatment is usually discontinued until levels normalize.

Contraindications and Safety Limitations

Silkis is contraindicated in patients with pre-existing hypercalcaemia, known abnormal calcium metabolism, or severe kidney or liver dysfunction. Safety in children under 18 years of age has not been established, and use is not recommended for this population.

Key safety-related restrictions include:

  • Ultraviolet (UV) Exposure: Avoid excessive exposure to natural or artificial sunlight, including tanning beds, as the ointment vehicle may enhance the risk of UV-induced skin tumours.
  • Occlusion: The treated skin area must not be covered with an occlusive dressing or bandage, which could increase calcitriol absorption.
  • Fire Hazard: Fabric (clothing, bedding, dressings) that has been in contact with the product may burn more easily, posing a serious fire risk. Patients should be warned not to smoke or go near naked flames.

Overdose and Emergency Response

Overdose and When to Seek Help

Overuse of Silkis (calcitriol ointment) or accidental ingestion may lead to systemic side-effects, primarily associated with elevated calcium levels in the blood (hypercalcaemia) due to the active ingredient's similarity to Vitamin D.

Overdose Manifestations When to Seek Medical Attention
Signs of high calcium: upset stomach, nausea, vomiting, loss of appetite, constipation, excessive thirst, or increased urination. Immediately: If the ointment is accidentally swallowed by anyone.
Neurological symptoms: general weakness, lethargy, depression, and, rarely, coma. Urgently: If signs of high calcium levels are noted, or if there is excessive application.

If you have applied an excessive amount of the ointment or suspect an overdose, you should contact a healthcare professional, physician, or local poison control center for guidance. If laboratory tests confirm hypercalcaemia or hypercalciuria (high calcium in urine), use of the ointment must be discontinued until calcium levels return to the normal range, as directed by a healthcare provider. The primary risk is a disturbance of calcium balance; therefore, monitoring blood and urine calcium levels is essential following excessive exposure.

Therapeutic Uses of Silkis

Main Uses of Silkis

Silkis is a topical medication primarily used for the treatment of mild to moderate plaque psoriasis (psoriasis vulgaris). It is specifically indicated for cases where the affected areas involve up to 35% of the body surface area.

As a vitamin D3 derivative, the active substance works by addressing the underlying biological processes in the skin that lead to the formation of psoriatic plaques. Unlike systemic treatments, it is applied directly to the skin to manage localized symptoms.

Therapeutic Benefits

The primary goal of treatment is to improve the appearance and physical sensation of the skin. The medication offers several clinical benefits for those managing chronic plaque psoriasis:

  • Regulation of Skin Cell Production: It helps normalize the excessive production of skin cells (keratinocytes), which is the primary cause of the thick, scaly patches characteristic of psoriasis.
  • Reduction of Scaling: By slowing down cell turnover, the medication reduces the accumulation of dead skin cells, leading to a visible thinning of the silvery scales.
  • Management of Inflammation: The treatment helps to decrease the redness and swelling of the affected skin areas.
  • Long-term Maintenance: It can be used as part of a management plan to maintain skin clarity over extended periods, helping to control the progression of existing plaques.

Effectiveness in Plaque Psoriasis

Plaque psoriasis is the most common form of the condition, typically presenting as raised, red patches covered with a silvery-white buildup of dead skin cells. This medication is specifically formulated to penetrate these plaques and act on the skin layers beneath to restore a more typical skin growth cycle.

Regulatory References

  1. MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Silkis?

The official eligibility profile for Silkis (calcitriol) ointment is strictly defined by regulatory authorities based on metabolic status, age, and organ health.


Contraindicated Populations

Silkis is contraindicated (must not be used) in patients with pre-existing hypercalcemia (high blood calcium) or any known abnormal calcium metabolism. Patients on systemic treatment of calcium homeostasis are also strictly excluded. Some international regulatory bodies contraindicate use in patients with severe kidney dysfunction or liver problems.

Age-Related Eligibility

Eligibility for age groups varies regionally. The US FDA approves use for adults and children aged 2 years and older. However, regulatory bodies like the EMA state the medicine is generally not recommended for patients under 18 years of age due to limited safety data. Use is not established for infants under 2 years.

Application Site Restrictions

The ointment must not be applied to the face, eyes, or lips, or under occlusive dressings (e.g., bandages) for any eligible population. Breastfeeding women are restricted from applying the ointment directly to the nipple or areola.

What should I know about interactions with other medicines?

The official regulatory documents define the interaction profile of Silkis (calcitriol) ointment primarily around potential pharmacodynamic effects related to calcium and local skin tolerance.

Co-administration with other products that elevate systemic calcium levels must be approached with caution due to the risk of an additive effect on serum calcium. Interacting substances include thiazide diuretics, calcium supplements, and systemic or high-dose Vitamin D products. This documented interaction may result in elevated serum calcium levels. Furthermore, the label notes that the action of certain medications, such as Digoxin, may be modified by changes in calcium blood levels.

In the topical context, the concomitant use of peeling agents, astringent agents, or other irritant products may produce additive local irritant effects on the treated skin.

A critical administration restriction designed to prevent increased systemic absorption is that the ointment must not be covered with an occlusive dressing or applied with substances that stimulate absorption.

The use of this medication is officially contraindicated in patient populations with conditions that amplify interaction risks, such as pre-existing hypercalcaemia, abnormal calcium metabolism, or known kidney or liver dysfunction, as these conditions heighten the risk of severe interaction outcomes related to calcitriol exposure.

Mechanism of Action

The biological effect of Silkis (Calcitriol) is initiated by its function as a high-affinity agonist for the nuclear Vitamin D Receptor (VDR), which is widely expressed in skin and immune cells.

Calcitriol's mechanism operates within two distinct mechanistic domains.

Cellular Growth and Differentiation Control

This domain involves the modulation of gene transcription in keratinocytes, the principal cells of the epidermis. Calcitriol binding to the VDR/RXR complex leads to the activation or repression of specific genes that control cell development. This cascade functions to inhibit the hyperproliferation (excessive division) of keratinocytes and simultaneously induce normal differentiation (maturation). The resulting physiological effect is the reduction of epidermal hyperplasia.

Localized Immunomodulation

Calcitriol also acts on local immune cells, particularly T lymphocytes, via the VDR to modulate the inflammatory cascade. This engagement suppresses the proliferation and activation of these immune cells and limits the production of key pro-inflammatory cytokines (chemical messengers) such as IL-2 and IFN-gamma. This targeted interference results in the modulation of activity within the immune pathway. The physiological consequence of this is the attenuation of cutaneous inflammatory signaling.

Dosage and Administration Information

Instruction Map: How to use Silkis — Administration Guidelines

The usage of Silkis ointment is governed by specific guidelines defining its administration route, frequency, and maximum application limits.

Administration Scope Detail
Route of administration Topical (external use) only; it is not for oral, ophthalmic, or internal application.
Dosing schedule The standard dose for affected areas is a thin layer applied twice daily. The maximum weekly dose for adults and children 7 years and older must not exceed 200 grams.
Age-group administration rules A lower maximum weekly dose of 100 grams is established for children aged 2 to 6 years.
Special procedural conditions The ointment must be applied only to skin areas affected by psoriasis. Treated areas should not be covered with an occlusive dressing or bandage.

Instruction Classifications (High-Level)

Silkis is classified for Topical administration, with a standard Twice daily frequency pattern. If a dose is missed, it should be applied as soon as remembered, unless it is nearly time for the next scheduled dose, in which case the missed application should be skipped.


Resulting Procedural Structure

The step sequence involves applying the ointment in a thin layer and gently rubbing it into the skin until it is no longer visible, performing this application twice daily (morning and evening). Users are instructed to wash hands thoroughly after application, unless the hands themselves are being treated.


This protocol establishes precise boundaries for external use, dictates a specific dosing routine, and sets clear maximum weekly dose ceilings based on the patient's age. These standards ensure the medicine is administered in accordance with the defined instructions.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Silkis (Calcitriol)

The research base for calcitriol ointment used for mild to moderate chronic plaque psoriasis includes Randomized Controlled Trials (RCTs). These short-term studies were typically conducted over several weeks, where researchers monitored the use of the calcitriol ointment against a vehicle (a placebo version of the ointment without the active ingredient) in adult patients. Studies explored how symptoms evolved in the observed populations, with outcomes related to assessing physical changes.

Research examined several key outcomes related to changes in the visible signs of psoriasis, including the measured severity of redness (erythema), the level of scaling, and the thickness (induration) of the plaques. The body of evidence was submitted to regulatory authorities for review related to this indication, and findings contribute to understanding symptom patterns. However, the primary, highly controlled efficacy trials were often of short duration. Data are still emerging regarding patterns of change when compared directly against certain other established, standard topical therapies over extended periods.

Research on Application to Sensitive and Thin-Skinned Areas

Silkis ointment has also been evaluated in studies that specifically looked at its application on sensitive skin areas, such as the face, neck, and skin folds. Comparative trials were used in research exploring differences in local reactions when calcitriol was applied versus some other topical treatments used for psoriasis. Findings describe patterns observed in these studies, where some studies reported differences in local tolerance (irritation at the application site) when calcitriol was compared to certain other topical vitamin D analogue formulations. This evidence contributes to the broader evidence landscape by characterizing its tolerability profile in body areas that were examined for skin sensitivity.

Research Gaps and Areas of Uncertainty

The research primarily focused on mild to moderate forms of the condition; evidence remains limited for the role of calcitriol in patients with more severe, widespread disease. While patterns of local tolerance have been observed, the comparative effects against all other major topical therapies are not yet fully established in the research.

Key Studies & References

  1. Calcitriol Topical - MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Silkis (FAQ)

Q: How long does it usually take to see a difference after starting Silkis?

The research used to support the medicine's regulatory approval involved studies conducted over several weeks. Official product information notes that clinical experience with this specific dosage regimen is generally limited to periods of no more than six weeks of use.

Q: Can I use other lotions or moisturizers with Silkis?

Official guidance advises against using irritant products, such as peeling or astringent agents, concurrently with Silkis, as this may lead to additive local irritation. Regulatory documents note that the ointment should not be mixed with or applied alongside any substance that could stimulate increased absorption of the active ingredient.

Q: Is it normal to feel a slight burning sensation when I first use Silkis?

Local skin discomfort, skin irritation, and redness (erythema) are commonly documented adverse reactions in the official safety profile. Official guidance notes that in the event of severe irritation or a suspected contact allergy, the treatment is typically discontinued.

Q: Can Silkis cream make the skin more sensitive to the sun?

Official guidance advises avoiding excessive exposure to natural or artificial sunlight, including tanning beds, while using the ointment. This restriction is because the ointment's vehicle (the base of the cream) may enhance the potential risk of developing UV-induced skin tumours.

Q: What happens if I accidentally use Silkis on skin that is not affected by the condition?

The medication is intended only for application to the areas of the skin affected by psoriasis. Official instructions include washing hands thoroughly after application to prevent unintentionally spreading the ointment to non-lesional areas.

Q: Is Silkis the same as other vitamin D creams?

Silkis contains the active ingredient calcitriol, which is classified as a specific type of Vitamin D Analog. While it belongs to the same pharmacological class as other topical treatments for psoriasis, other 'Vitamin D creams' may contain different active substances, which may have distinct characteristics.

Q: Why do dermatologists prescribe Silkis?

Official documents define Silkis as a non-steroidal topical agent approved for the management of mild to moderate chronic plaque psoriasis. Its established mechanism of action involves regulating the excessive growth of skin cells and modulating localized inflammation.

Q: Does Silkis cause skin thinning?

The most commonly documented side effects are local adverse reactions, such as irritation and redness. The official documentation does not list skin thinning (atrophy) as a documented side effect of this medication.

Q: Is there a maximum amount of time I can use Silkis?

Regulatory documents note that clinical experience with the use of this medication at the defined dosage regimen is limited to periods not exceeding six weeks. Any use beyond this period falls outside the scope of the primary clinical data.

Q: Do you need a prescription for Silkis?

Yes, official product information classifies Silkis as a Prescription Only (Rx) medication. It is not available as an Over-The-Counter (OTC) product.

Q: What should I do if my skin gets very red after applying Silkis?

Redness (erythema) is a commonly documented adverse reaction. Official guidance notes that in the event of severe irritation or a suspected allergic reaction, the treatment is typically discontinued.

Q: Does using more Silkis make it work faster?

Official warnings state that applying the medication in excess will not result in more rapid or better outcomes. Excessive application may, in fact, lead to marked redness, peeling, or discomfort.

Q: Are there any foods or supplements that interact with Silkis?

The official label specifies that the co-administration of products that elevate systemic calcium levels, such as calcium supplements and systemic Vitamin D products, must be approached with caution. This is due to the potential risk of an additive effect on serum calcium levels.

Q: Is Silkis known to cause any long-term side effects?

Clinical experience regarding the use of the drug for periods longer than six weeks is limited. A significant safety restriction noted that relates to long-term risk is the necessity to avoid excessive UV light exposure.

Q: What is the consistency of Silkis cream like?

According to the pharmaceutical form described in regulatory documents, the product is an ointment that is white and translucent in appearance.

Q: Is Silkis available over-the-counter in any countries?

No, based on official regulatory classification, Silkis is designated as a Prescription Only (Rx) medication in the countries where its label is reviewed.

Q: Does the time of day I apply Silkis matter?

The official administration schedule is defined as two applications per day, specifically once in the morning and once in the evening before retiring.

How should Silkis be stored and disposed of?

Official Storage and Disposal Requirements

Silkis (calcitriol) ointment must be stored and handled according to the following regulatory guidelines to maintain product stability and safety:

Storage Conditions:

  • Store the ointment at controlled room temperature (20 C to 25 C / 68 F to 77 F).
  • The product must not be refrigerated or frozen.
  • Keep Silkis out of the sight and reach of children.

Stability and Disposal:

  • The product has a labeled shelf-life of 8 weeks after the first opening; any remaining ointment must be discarded after this period.
  • Do not dispose of the medicine via household trash or down the drain.
  • Unused or expired product should be properly disposed of by consulting a pharmacist for instructions.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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