Skinoren 20% cream

What is Skinoren?

Skinoren 20% Cream is a prescription-only medicine applied to the skin. Each gram contains 200 mg of azelaic acid (azelaic acid 20% w/w), and it is a white, opaque cream supplied in an aluminium tube; the SmPC lists 20 g, 30 g and 50 g tubes, although not all pack sizes are marketed. The marketing authorisation holder is LEO Laboratories Limited (PL 00043/0236).

In the UK, Skinoren is licensed for one condition: the topical treatment of acne vulgaris, the common form of acne. The patient leaflet is explicit that the cream should only be used to treat acne and not for any other skin condition. Acne vulgaris is the condition in which the pores of the skin become blocked and inflamed, producing blackheads, whiteheads and spots, most often on the face and sometimes on the chest and back.

How does Skinoren work?

The patient leaflet explains that Skinoren attacks the bacterium Propionibacterium acnes, which plays an essential part in causing acne, and reduces the growth of the harder outermost skin cells that block the pores to cause blackheads and whiteheads. The SmPC describes the same two actions: an antimicrobial effect and a direct influence on follicular hyperkeratosis (the thickening of the lining of the hair follicles) are assumed to be the basis of its effect in acne.

In clinical use, a significant reduction in the density of Propionibacterium acnes on the skin and in the proportion of free fatty acids in the skin-surface lipids has been observed. In laboratory and animal studies, azelaic acid inhibits the proliferation of keratinocytes (the main cells of the outer skin) and normalises the disturbed keratinisation process seen in acne.

How to use Skinoren Cream

Always use Skinoren exactly as your prescriber has told you, and read the patient information leaflet in your pack.

• Before applying the cream, wash the whole area to be treated thoroughly with plain water and dry it. If the skin is greasy, a mild skin cleanser may be used.
• Apply Skinoren to the affected areas of skin twice a day, in the morning and in the evening, and rub it in gently. As a guide, 2.5 cm of cream (about 0.5 g) is enough for the whole face; if acne on the chest or back is also being treated, adjust the amount accordingly.
• If your skin is very sensitive, use Skinoren once a day, in the evening, for the first week of treatment, then change to twice a day.
• Wash your hands thoroughly after each application.
• Avoid contact with the eyes, mouth and other mucous membranes. If the cream gets into the eyes or mouth, wash with large amounts of water, and consult a doctor if eye irritation persists.
• If your skin becomes irritated, use less cream per application or reduce to once a day until the irritation settles. If necessary, stop for a few days.
• Store the tube below 30°C; once opened, it is for use within 6 months.

It is important to use Skinoren regularly over the whole period of treatment. The leaflet advises that Skinoren should not be used for more than 12 months at any time.

How long does Skinoren take to work?

According to the SmPC, a distinct improvement generally becomes apparent after about 4 weeks of treatment. How long Skinoren needs to be used varies from person to person and depends on the severity of the acne; the SmPC advises using it continuously over a period of several months. There is clinical experience of continuous use for up to one year, and the patient leaflet says not to use Skinoren for more than 12 months at any time.

Possible side effects of Skinoren

Like all medicines, Skinoren can cause side effects, although not everybody gets them. Those listed in the SmPC mainly affect the skin where the cream is applied:

• Very common (may affect more than 1 in 10 people): burning, itching and redness (erythema) at the application site.
• Common (may affect up to 1 in 10 people): scaling, pain, dryness, discolouration and irritation at the application site.
• Uncommon (may affect up to 1 in 100 people): greasy skin (seborrhoea), acne, loss of skin colour (depigmentation), and tingling, dermatitis, discomfort or swelling at the application site.
• Rare (may affect up to 1 in 1,000 people): cracked lips (cheilitis), small blisters, eczema, warmth or ulceration at the application site, allergic reaction (drug hypersensitivity) and worsening of asthma.
• Not known (frequency cannot be estimated): rash, hives (urticaria), and swelling under the skin (angioedema), contact dermatitis, eye swelling or swelling of the face, which may occur with hypersensitivity.

Local skin irritation usually occurs at the start of treatment, is mild in most cases and generally lessens as treatment continues. Stop using Skinoren and see your doctor as soon as possible if you think you are having an allergic reaction, for example a rash. Suspected side effects can be reported through the MHRA Yellow Card scheme.

Precautions when using Skinoren

• Skinoren is for external use on the skin only.
• Avoid contact with the eyes, mouth and other mucous membranes, and wash your hands after each application. In the event of accidental contact, wash with large amounts of water; if eye irritation persists, consult a doctor.
• Worsening of asthma has been reported rarely in people treated with azelaic acid. Tell your prescriber if you have asthma.
• Skinoren contains benzoic acid (2 mg per gram), which may cause local irritation, propylene glycol (125 mg per gram), and cetostearyl alcohol, which may cause local skin reactions such as contact dermatitis.
• Pregnancy and breastfeeding: there are no adequate, well-controlled studies of topical azelaic acid in pregnant women, so it is prescribed with caution in pregnancy. Caution is also advised when breastfeeding; very little azelaic acid is thought to reach the baby through milk, but infants must not come into contact with treated skin or the breast. Tell the prescriber if you are pregnant, planning a pregnancy or breastfeeding.
• Children: Skinoren is not recommended for children under 12 years of age because safety and efficacy have not been established; no dose adjustment is needed for adolescents aged 12 to 18.
• Skinoren has no influence on the ability to drive or use machines.
• No interaction studies have been performed with Skinoren. Tell the prescriber or pharmacist about any other medicines you are using, including other acne treatments applied to the skin.

Who should not use Skinoren

Do not use Skinoren if you are allergic (hypersensitive) to azelaic acid or to any of the other ingredients: benzoic acid (E210), cetearyl octanoate with isopropyl myristate (PCL Liquid), glycerol 85%, propylene glycol, purified water, stearoyl macrogolglycerides, glycerol monostearate 40-55 and cetostearyl alcohol.

Skinoren is also not recommended for children under 12. If you are pregnant or breastfeeding, have asthma, or have reacted to a skin product before, tell the prescriber during your consultation so that they can decide whether Skinoren is suitable for you.

Skinoren vs Finacea

Skinoren and Finacea both contain azelaic acid and are made by LEO Laboratories, but they are different products:

• Strength and form: Skinoren is a 20% cream (200 mg of azelaic acid per gram), a white opaque cream. Finacea is a 15% gel (150 mg per gram), a white to yellowish-white opaque gel.
• Licensed uses: Skinoren is licensed for the topical treatment of acne vulgaris only. Finacea is licensed for the topical treatment of papulopustular rosacea and for mild to moderate papular-pustular acne of the face.
• Rosacea: Skinoren is not licensed for rosacea. If you have been diagnosed with rosacea, Finacea is the azelaic acid product licensed for the condition.
• How a prescriber chooses: for acne, either may be considered; the prescriber takes into account your diagnosis, where the acne is (the Skinoren leaflet covers the chest and back as well as the face), how your skin has reacted to treatments before, and whether a cream or a gel suits your skin.

Is Skinoren available on the NHS?

Yes. Skinoren can be prescribed on the NHS by a GP or a dermatologist where they consider it appropriate, and the usual NHS prescription charge or exemption applies. MediHealth Direct supplies Skinoren on a private prescription after an online consultation, so the price shown on this page is the private cost of the medicine, not an NHS charge.

Patient information leaflet

Read the official leaflet before you use Skinoren and keep it for reference: Skinoren 20% Cream patient information leaflet (medicines.org.uk). The prescriber information this page is based on is the Skinoren Summary of Product Characteristics.

Getting Skinoren from MediHealth Direct

Skinoren is a prescription-only medicine, so it can only be supplied against a prescription. To request it, complete an online consultation about your skin and your medical history. A UK-registered prescriber reviews your answers and decides whether Skinoren is appropriate for you; if it is, a private prescription is issued and the medicine is dispensed by our GPhC-registered pharmacy. If a different treatment would suit you better, the prescriber will say so.

FAQs about Skinoren

How long does it take for Skinoren to work?

According to the Skinoren SmPC, a distinct improvement generally becomes apparent after about 4 weeks of treatment. The time needed varies from person to person and depends on how severe the acne is, and the SmPC advises using the cream continuously over several months. Keep applying it regularly through the whole course; if you are unsure whether it is working, ask your prescriber or pharmacist rather than stopping.

Can I use Skinoren during pregnancy?

There are no adequate, well-controlled studies of topical azelaic acid in pregnant women, so the SmPC advises caution when Skinoren is prescribed in pregnancy. The patient leaflet says to ask your doctor or pharmacist for advice before using it if you are pregnant, think you may be pregnant or are planning a baby. Tell the prescriber during your consultation so that they can decide whether Skinoren is suitable for you.

What should I do if Skinoren irritates?

Local skin irritation can occur, usually at the start of treatment, and in most cases it is mild and settles as treatment continues. If it remains troublesome, the leaflet advises reducing the amount of cream you apply, applying it only once a day, or stopping temporarily for a few days. If the irritation still does not settle, or you think you are having an allergic reaction such as a rash, stop and see your doctor.

Is Skinoren available over the counter?

No. Skinoren 20% Cream is a prescription-only medicine in the UK, so a pharmacy can supply it only against a prescription from a doctor or another qualified prescriber. A GP or dermatologist can prescribe it on the NHS. MediHealth Direct supplies it on a private prescription: you complete an online consultation, a UK-registered prescriber reviews your answers and, if Skinoren is appropriate, our pharmacy dispenses it.

Is Skinoren suitable for sensitive skin?

Skinoren can be used on sensitive skin, but the SmPC and leaflet advise a gentler start: apply it once a day, in the evening, for the first week of treatment, then move to twice a day. Very common side effects are burning, itching and redness where the cream is applied, which generally lessen as treatment continues. If irritation persists, reduce the amount or the frequency and ask your pharmacist for advice.

How long can I use Skinoren?

How long Skinoren needs to be used depends on the severity of your acne; the SmPC advises continuous use over a period of several months and describes clinical experience of continuous use for up to one year. The patient leaflet says not to use Skinoren for more than 12 months at any time. Your prescriber will advise when to review the treatment and whether to continue, pause or change it.

Does Skinoren help with acne scars?

Skinoren is licensed for the topical treatment of acne vulgaris, meaning active spots, blackheads and whiteheads. Neither the SmPC nor the patient leaflet describes an effect on acne scarring, so this page makes no claim about scars. Treating active acne is what the licence covers; if scarring is your main concern, ask your prescriber or a dermatologist about options that are assessed for it.

What is Skinoren used for?

Skinoren 20% Cream is licensed in the UK for the topical treatment of acne vulgaris, the common form of acne with blocked pores, blackheads, whiteheads and inflamed spots. The leaflet states that it should only be used to treat acne and not any other skin condition. It is applied to the affected skin twice a day, and can be used on the chest and back as well as the face where acne affects those areas.

Can Skinoren be used for rosacea?

No. Skinoren is licensed for acne vulgaris only, and its leaflet says it should not be used for any other skin condition. Azelaic acid is also available as Finacea 15% gel, which is the azelaic acid product licensed for papulopustular rosacea. If you have been diagnosed with rosacea rather than acne, tell the prescriber during your consultation so that they can consider a treatment licensed for it.

Skinoren vs Finacea — what's the difference?

Both contain azelaic acid and are made by LEO Laboratories, but they differ in strength, form and licence. Skinoren is a 20% cream licensed for acne vulgaris only. Finacea is a 15% gel licensed for papulopustular rosacea and for mild to moderate papular-pustular acne of the face. For rosacea, Finacea is the licensed product; for acne, a prescriber chooses between them based on your diagnosis and skin.

Can I use Skinoren with other acne treatments?

No interaction studies have been performed with Skinoren, so the SmPC gives no guidance on combining it with other acne products. Tell the prescriber about every treatment you use on your skin or take by mouth, including gels, washes and antibiotics, and do not add another acne product yourself. Whether a combination is appropriate is a prescribing decision made on your diagnosis and how your skin has reacted before.