Solaraze Gel

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Solaraze Gel on Prescriptsy

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Solaraze Gel contains diclofenac sodium 3% in a hyaluronic acid gel base and is licensed for the topical treatment of actinic keratosis (solar keratosis) in adults.

Actinic keratoses are rough, scaly, or crusty patches of skin caused by cumulative exposure to ultraviolet (UV) radiation over many years.

They most commonly appear on sun-exposed areas such as the face, scalp (particularly in men with thinning hair or baldness), ears, backs of the hands, and forearms.

Actinic keratoses are considered pre-cancerous lesions because a proportion can progress to squamous cell carcinoma (SCC) if left untreated.

Solaraze offers a non-invasive topical treatment that can be self-applied at home. It is a prescription-only medicine (POM) manufactured by Almirall.

This page provides a detailed clinical guide to Solaraze Gel, covering how it works, dosage instructions, side effects, safety warnings, and how to obtain it in the United Kingdom.

Actinic keratosis is the most common pre-malignant skin condition in the UK, with prevalence increasing significantly with age, fair skin type, and cumulative sun exposure.

In adults over 60 living in the UK, an estimated 15% to 25% have at least one actinic keratosis.

The condition is particularly common in people who have worked outdoors (farmers, builders, gardeners), have fair skin (Fitzpatrick skin types I and II), have a history of sunburn, or have used sunbeds.

While the risk of any individual actinic keratosis progressing to SCC is relatively low (estimated at 0.025% to 16% per lesion per year, depending on the study and population), patients often have multiple lesions, and the cumulative risk across a field of sun-damaged skin is significant.

Early treatment reduces this risk and can also improve the cosmetic appearance of affected skin.

Important safety information about Solaraze Gel

Before reading further, please note these essential safety points.

• Solaraze Gel contains diclofenac, an NSAID. Do not use it if you have had an allergic reaction (asthma, hives, or swelling) to aspirin, ibuprofen, or any other NSAID.
• Protect treated skin from sunlight during the treatment course, as Solaraze may increase photosensitivity.
• Do not apply Solaraze to open wounds, broken skin, or mucous membranes, and avoid contact with the eyes.
• Treatment typically takes 60 to 90 days. Complete the full course even if the skin appears to improve sooner.
• Any suspicious skin lesion that changes in size, shape, colour, or starts bleeding should be assessed by a doctor promptly.

Understanding actinic keratosis

Actinic keratosis develops when keratinocytes in the epidermis accumulate UV-induced DNA mutations, particularly in the tumour suppressor gene p53.

These mutations cause the affected keratinocytes to proliferate abnormally, forming visible patches of rough, thickened, or scaly skin.

The lesions are typically flat or slightly raised, ranging in size from a few millimetres to over 2 centimetres, and may be skin-coloured, pink, red, or brown.

They often feel rough or sandpapery to the touch. Some lesions develop a hard, horn-like projection known as a cutaneous horn.

Actinic keratoses can be tender, itchy, or asymptomatic.

The concept of field cancerisation is important in understanding actinic keratosis. Clinically visible lesions represent only a fraction of the UV-damaged skin in a given area.

Surrounding apparently normal skin contains subclinical foci of dysplastic keratinocytes that may develop into visible lesions over time or may undergo malignant transformation directly.

This is why field-directed therapies, such as Solaraze Gel, which treat the entire affected area rather than individual spots, can be advantageous over lesion-directed treatments like cryotherapy.

How Solaraze Gel works

Diclofenac sodium is a non-selective cyclooxygenase (COX) inhibitor that reduces the synthesis of prostaglandins, thromboxanes, and prostacyclin from arachidonic acid.

In actinic keratosis, COX-2 is significantly upregulated in dysplastic keratinocytes.

The resulting overproduction of prostaglandin E2 (PGE2) promotes several processes that favour tumour development: increased cell proliferation, resistance to apoptosis (programmed cell death), stimulation of angiogenesis (new blood vessel formation to supply the growing lesion), and suppression of local immune surveillance.

By inhibiting COX-2, topical diclofenac reverses these effects, restoring normal rates of apoptosis, reducing proliferation, and enabling the immune system to recognise and clear abnormal cells.

The hyaluronic acid 2.5% gel base serves a dual purpose.

It acts as an occlusive carrier that prolongs contact time between diclofenac and the skin surface, enhancing penetration into the epidermis where dysplastic keratinocytes reside.

Hyaluronic acid is also a natural component of the extracellular matrix with hydrating properties, which helps maintain skin moisture during treatment and may reduce local irritation.

Systemic absorption of diclofenac from Solaraze Gel is substantially lower than from oral diclofenac preparations.

Studies have shown that plasma concentrations of diclofenac following topical application of Solaraze are typically less than 10 ng/mL, compared with peak concentrations of approximately 1,000 to 2,000 ng/mL after a standard oral dose.

This greatly reduces the risk of systemic NSAID side effects such as gastrointestinal ulceration, renal impairment, and cardiovascular events.

Clinical evidence for Solaraze Gel

The efficacy of Solaraze Gel has been demonstrated in several randomised, double-blind, placebo-controlled trials.

In a pivotal study, complete clearance of actinic keratosis lesions was achieved in 33% of patients treated with Solaraze for 90 days, compared with 10% of those treated with placebo gel.

A further 17% achieved partial clearance (at least 50% reduction in lesion count).

In a combined analysis of two phase III trials, complete clearance at 30 days post-treatment was approximately 50% in the diclofenac group, reflecting the delayed therapeutic effect that continues after treatment ends.

Long-term follow-up studies have shown that lesions cleared by Solaraze Gel have a recurrence rate of approximately 20% to 25% over 12 months, which is comparable to other topical treatments for actinic keratosis.

Repeat courses of Solaraze can be used for recurrent lesions.

Solaraze compared with other treatments

Several treatment options are available for actinic keratosis in the UK.

Cryotherapy (liquid nitrogen) is the most commonly used lesion-directed treatment and is effective for individual or scattered lesions.

It is quick, performed in the clinic, and does not require patient self-application. However, it treats only visible lesions and does not address subclinical field damage.

Fluorouracil 5% cream (Efudix) is a cytotoxic agent that causes widespread inflammation and crusting of treated skin, producing high clearance rates but significant local side effects.

Imiquimod 5% cream (Aldara) is an immune response modifier that stimulates local immunity against dysplastic cells.

Photodynamic therapy (PDT) involves applying a photosensitising agent (5-aminolaevulinic acid or methyl aminolaevulinate) followed by exposure to a specific wavelength of light.

Solaraze Gel is generally the best tolerated of the field-directed topical treatments.

Its side effects are milder than those of fluorouracil or imiquimod, making it a suitable option for patients who are unable or unwilling to tolerate the intense inflammatory reaction associated with those alternatives.

The trade-off is that Solaraze has slightly lower clearance rates and requires a longer treatment duration (60 to 90 days compared with 2 to 4 weeks for fluorouracil).

Dosage and administration

Apply Solaraze Gel twice daily to the affected skin areas.

Use approximately 0.5 grams (a pea-sized amount) per lesion, gently smoothing it over the entire keratosis and a small margin of surrounding skin.

The total daily dose should not exceed 8 grams. Continue treatment for 60 to 90 days as directed by your prescriber.

Do not stop treatment early even if the skin appears to be improving, as the full course is needed for optimal results.

Apply to clean, dry skin. Allow the gel to dry before applying sunscreen, moisturiser, or cosmetics. Do not cover the treated area with airtight dressings.

Wash your hands after application unless the hands are the treatment area. Avoid contact with eyes, mouth, and broken skin.

Full clearance may not be apparent until 30 days after completing the course, as the anti-proliferative and immune-restoring effects of diclofenac continue beyond the application period.

Your prescriber or dermatologist will review the treated areas after this period to assess the response.

Side effects of Solaraze Gel

Common local reactions

Skin reactions at the application site are the most frequently reported side effects. These include redness (erythema), itching (pruritus), dryness, scaling, burning, stinging, and rash.

These effects occur in approximately 15% to 30% of users and are usually mild to moderate.

They typically begin within the first 1 to 2 weeks of treatment and may fluctuate in intensity throughout the course.

Some degree of redness and peeling may indicate that the gel is working, as dysplastic cells are being cleared.

Less common local effects

Contact dermatitis, localised oedema (swelling), and vesiculation (blistering) have been reported occasionally. If blistering, severe irritation, or spreading rash occurs, stop using Solaraze and consult your prescriber.

Photosensitivity

Solaraze may increase the sensitivity of treated skin to UV radiation. Sunburn-like reactions have been reported in treated areas following sun exposure.

Protect treated skin from sunlight throughout the treatment period and for at least two weeks after stopping. Use a broad-spectrum SPF 30+ sunscreen on exposed treatment areas.

Systemic side effects

Because systemic absorption is low, systemic NSAID side effects (gastrointestinal ulceration, renal impairment, cardiovascular events) are very uncommon. Rare reports of headache, nausea, and abdominal discomfort have been noted, particularly when large areas are treated.

Report suspected adverse reactions to the MHRA at yellowcard.mhra.gov.uk.

Warnings and precautions

Contraindications

Do not use Solaraze Gel if you are allergic to diclofenac, aspirin, or any other NSAID.

Patients with a history of NSAID-exacerbated asthma, urticaria, or angioedema must not use this product.

Do not apply to open wounds, infected skin, severely inflamed skin, or mucous membranes.

Pregnancy and breastfeeding

Solaraze should not be used during the third trimester of pregnancy, as NSAIDs may cause premature closure of the fetal ductus arteriosus, prolonged labour, and oligohydramnios.

Use during the first and second trimesters should be avoided unless clearly necessary.

Small amounts of diclofenac may enter breast milk; avoid applying the gel to the breast area and discuss with your prescriber before use during breastfeeding.

Sun protection

Actinic keratoses are caused by UV damage, and continued sun exposure promotes the development of new lesions and increases the risk of progression to SCC.

Sun protection is an essential part of management, both during and after Solaraze treatment. Wear protective clothing, broad-brimmed hats, and SPF 30+ sunscreen on exposed skin.

Avoid midday sun when UV intensity is highest.

When to seek further advice

Any skin lesion that grows rapidly, bleeds, ulcerates, changes colour, or becomes painful should be assessed by a dermatologist or GP promptly, as these features may indicate progression to squamous cell carcinoma.

NICE recommends urgent referral for suspected skin cancer under the 2-week-wait pathway.

How to get Solaraze Gel in the UK

Solaraze Gel is available on NHS prescription from your GP, dermatologist, or an authorised online prescriber registered with the General Pharmaceutical Council (GPhC).

The standard NHS prescription charge in England is 9.90 pounds per item; prescriptions are free in Scotland, Wales, and Northern Ireland. Solaraze may also be prescribed privately.

Your GP or pharmacist can advise on the most cost-effective option.

Sources

• Solaraze 3% Gel, Summary of Product Characteristics (EMC)
• Diclofenac sodium, British National Formulary (BNF)
• Actinic keratosis, NICE CKS
• Actinic keratoses (solar keratoses), NHS
• MHRA Yellow Card Scheme