Formulary

Treatment of actinic keratoses

First Line
Second Line
Specialist
Hospital Only

Actinic keratoses (AKs) are red or brown flat scaly lesions that are rough to touch. They occur when sufficient chronic sun exposure allows for genetically damaged epidermis to exhibit clinical lesions. All of the skin is affected (field change) with the most damaged areas expressed as discrete lesions of variable thickness and scale. AKs can be itchy, scaly, rough, sore or bleed. Shallow ulceration can develop as well as persistent sterile pustulation. An uncertain but small percentage transform into squamous cell carcinoma (SCC). This is more likely to happen in immunocompromised patients, those with a previous SCC, elderly patients and extensive moderate / severe AKs. Not all AKs need treating but they should be identified.

Advice on available treatments, sun protection, risk of skin cancer and skin self-examination should be given. Since AKs are a marker for all types of skin cancer, the patient should be inspected on the arms, lower legs, chest, upper back, neck and head as a bare minimum examination.

All year round regular sun protection (which may include sunblock) will reduce the frequency of new visible lesions developing and mild lesions will regress.

The vast majority of AKs can be managed in primary care. To properly manage AKs, it is best to separate field change from separate lesions and stratify into mild, moderate and severe cases.

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Red flag signs that should prompt referral to secondary care are:

  • Immunosuppressed patients
  • Painful lesions
  • Cutaneous horns
  • Rapidly growing lesions
  • Deeply ulceration lesions and solitary lesions without convincing evidence of surrounding chronic sun damage
  • Pigmented facial lesions may also be very difficult to tell apart from lentigo maligna

Areas of treatment should not exceed 5cm x 5cm. Divide into sections for larger fields.

Sun-protection and Self-examination advice should be given to all patients

Differential diagnosis: seborrhoeic keratosis; dermatitis; Bowen's and SCC

Mild to Moderate AKs

Fluorouracil cream 5%
  • Apply thinly to the affected area once or twice daily; usual duration of initial therapy 3 – 4 weeks. Healing may not be complete until one or two months after therapy is stopped.
  • The SmPC for Efudix 5% cream indicates that the maximum area of skin treated at one time should not exceed 500cm2, however local specialists advise that areas of treatment should not exceed 5cm x 5cm, and that larger fields should be divided into sections.
  • Patients need to be counselled about the inflammatory reaction they will get which can be severe. Severe reactions should lead to a pause in treatment for a few days to allow the reaction to subside. Patients may use a greasy emollient and hydrocortisone 1% ointment or eumovate (clobetasone butyrate 0.05%) ointment can be applied if necessary whilst the reaction subsides.
  • Assess response approximately 8 weeks after completion of a 4-week course of treatment. If necessary, a second course of treatment may be considered in primary care unless there is diagnostic uncertainty / concern of a complication e.g SCC/BCC, in which case refer to secondary care
  • Caution: Flammable
  • See section 13.8.3 Preparations for actinic keratoses
Tirbanibulin ointment 1%
  • Apply once daily for 5 days. A thin layer of ointment should be applied to cover the treatment field of up to 25cm2 (5cm x 5cm).
  • May offer an alternative option in those who suffer unacceptable side effects with fluorouracil 5% cream.
  • Assess response approximately 8 weeks after treatment starts. If complete clearance is not demonstrated, recurrence occurs or new lesions develop in the treatment zone, alternative treatment options should be considered.
  • See section 13.8.3 Preparations for actinic keratoses

Moderate to Severe AKs

Fluorouracil cream 5%
  • Apply thinly to the affected area once or twice daily; usual duration of initial therapy 3 – 4 weeks. Healing may not be complete until one or two months after therapy is stopped.
  • The SmPC for Efudix 5% cream indicates that the maximum area of skin treated at one time should not exceed 500cm2, however local specialists advise that areas of treatment should not exceed 5cm x 5cm, and that larger fields should be divided into sections.
  • Patients need to be counselled about the inflammatory reaction they will get which can be severe. Severe reactions should lead to a pause in treatment for a few days to allow the reaction to subside. Patients may use a greasy emollient and hydrocortisone 1% ointment or eumovate (clobetasone butyrate 0.05%) ointment can be applied if necessary whilst the reaction subsides.
  • Caution: Flammable
  • See section 13.8.3 Preparations for actinic keratoses
Imiquimod cream 5%
  • Apply to lesions 3 times a week at night for 4 weeks and leave on skin for approximately 8 hours; assess response after a 4 week treatment-free interval; repeat 4-week course if lesions persist; maximum 2 courses
  • See section 13.7 Preparations for warts and callouses
Methyl-5-aminolevulinate cream (Metvix) with Photodynamic therapy (PDT)
  • Cream 160mg/g
  • With Photodynamic Therapy. Review response 3 months post treatment. Re-treat or refer if palpable lesions present.
  • Available in secondary or intermediate care.
  • For the treatment of AKs, Bowens disease and superficial BCC.
  • Useful in delicate skin at risk of ulceration and poor wound healing or where an alternative treatment would disfiguring.
  • Also useful for AK induced scalp erosive pustulosis.
Imiquimod 3.75% (Zyclara)

The routine commissioning of imiquimod 3.75% (Zyclara) is not accepted in Devon for the treatment of actinic keratosis (see Commissioning Policy for more details)

Mild

Sun-protection and self-examination advice

Moderate

Cryotherapy
  • Available in primary, intermediate and secondary care. Two freeze-thaw cycles of 10 seconds. Hyperkeratotic lesions unlikely to respond without debridement. Patient at risk from permanent hypo pigmentation or atrophic scarring.
Actikerall

(Fluorouracil 5mg/g (0.05%) with salicylic acid 100mg/g (10%) cutaneous solution)

Severe

Curettage and cautery (with pathology)
  • Hyperkeratotic lesions, cutaneous horns and where the index of suspicious of SCC transformation is high.
  • Always send each curetted specimen in a separate histology pot for pathology.
  • Review at 6 weeks post treatment. Re-treat or refer if lesion not resolved

Combination therapy should be used when the patient presents with both individual AKs and field change, although most topical agents will deal with mild to moderate individual lesions.