Compounded Topical Treatments for Actinic Keratosis: Prevent Skin Cancer Before It Develops

Compounded Topical Treatments for Actinic Keratosis: Prevent Skin Cancer Before It Develops

compounded topical treatmentsSome people learn early on that they have to be fanatical about limiting their exposure to the sun because their fair skin is so susceptible to severe sunburn. But a lot of people aren’t even close to careful.

As a result, more than 58 million people are estimated to have actinic keratosis, which is a scaly, precancerous patch of skin caused by exposure to ultraviolet rays.1 However, when they’re diagnosed at an early stage, compounded topical treatments for actinic keratoses can eliminate lesions and stop skin cancer from forming.

Approved Treatments and Long-Term Outcomes

The FDA has approved four pharmaceuticals for use as topical treatments for actinic keratosis (AK). Each one has a different mechanism of action, length of treatment and potential side effects. While that isn’t news to compounding pharmacists, a brief side-by-side comparison of the three primary treatments can help us anticipate patient’s concerns.

  • Ingenol mebutate, which is extracted from the milkweed plant, has a direct cytotoxic effect, stimulates neutrophils, and may have the ability to treat skin cells damaged by long-term exposure to ultraviolet light. It has the quickest effect, with improvement in three days, but patients may experience swelling and pain.2
  • 5-fluorouracil, or 5-FU, is the most commonly used topical for AK. The treatment regimen lasts two to four weeks, during which time the medication inhibits DNA synthesis. Skin irritation and blistering is common and it may take up to six weeks for skin to fully heal.3
  • Imiquimod stimulates the immune system to produce interferon, which destroys precancerous and cancerous cells. It’s generally well tolerated but treatment takes several months.4

Compounded Options for Sensitive Skin

The fourth FDA-approved medication, diclofenac, is an NSAID that can be mixed with creams or gels for topical treatment of AK. Whether used alone or with hyaluronic acid, diclofenac is recommended for patients who can’t tolerate other topical treatments due to sensitive skin and more extreme adverse reactions. Since diclofenac must be used for several months, compounding pharmacists can improve tolerability by choosing an emollient delivery base that helps maintain healthy skin.

The efficacy of topical diclofenac is inconsistently reported in the scientific literature. One systematic review rates it as equally effective as other field-tested topical treatments, another one found that 5-FU was superior to diclofenac and yet a third meta-analysis reported that 5-FU, ingenol mebutate, and imiquimod were more effective based on complete clearance of AK lesions. The bottom line for treatment decisions may come down to cost effectiveness.

Cost Considerations Determine Treatment Success

The risk of recurrence exists even when patients receive cryotherapy or photodynamic treatments. Imiquimod has the lowest recurrence rate, with about 10 percent of patients developing new lesions one year after treatment. Ingenol mebutate and 5-FU both have recurrence rates around 55 percent. Chronic recurrence of AK means that treatments may be needed throughout a patient’s life, which makes cost an important factor.

Determining cost effectiveness is a challenge because direct costs must be considered together with the length of treatment, concentration of medication, quality-of-life ratings and the patient’s willingness to pay for the duration of therapy. Most of the available studies aren’t much help because they compare topical treatments to photodynamic therapy. But two European studies published in 2015 compared the costs of the three primary topical treatments. Both concluded that ingenol mebutate was the most cost effective choice, especially when willingness to pay was considered.

Serve as a cost resource: For compounding pharmacists, cost-related issues represent an opportunity to establish new collaborations with medical professionals. Cost often determines whether a patient will follow through with treatment, so pharmacists can reach out to physicians and keep them apprised of overall costs, coverage by third-party payers, and cost savings programs available to patients.

 Prevention Outreach for Populations at Risk

Actinic keratosis is defined as a premalignant skin lesion, with about 10 percent of all cases developing into squamous cell carcinoma. The door for counseling is clearly open when patients come to fill prescriptions for treating AK, but compounding pharmacists can discuss prevention with patients long before that happens.

When dermatologists at Wake Forest School of Medicine evaluated data from the National Ambulatory Medical Care Survey, they discovered that most physicians don’t educate patients about sun-protective behaviors, even when the patient has a history of skin cancer.5 We can take the lead in prevention efforts by taking a few simple steps:

  • Target patients buying sunscreen products or OTC treatments for sunburn and talk to them about the risks of AK and sun protection.
  • Tell patients about the benefits of custom compounded topical medications using an emollient base.
  • Create a pamphlet about how to identify AK, the importance of early treatment to prevent cancer and topical treatment options.
  • The two biggest risk factors for AK and subsequent skin cancer are fair skin and exposure to sunlight. This information should be included in a pamphlet, but we can also use it to identify patients at risk.

Compounding Pharmacists as Key Resources

In a world where tanned skin is perceived as attractive and where people opt for tanning beds when they can’t get enough exposure to real sunlight, it’s not surprising to learn that actinic keratosis is the second most common diagnosis made by dermatologists. Compounding pharmacists can work together with patients and health care providers to foster prevention of actinic keratosis and to provide compounded topical treatments to prevent skin cancer.

Pharmaceutica North America has quality and cost-effective bulk APIs that target actinic keratosis. We specialize in irritant-free and emollient bases that are compatible with a wide range of pharmaceutical ingredients. Please contact us today to explore our products and discuss how we can support your pharmaceutical needs.  

Show 5 footnotes

  1. “Actinic Keratosis,” 2015,
  2. “Ingenol Mebutate Can Cause Severe Allergic Reactions and Herpes Zoster (Shingles),” August 2015,
  3. “Ingenol Mebutate (Picato) Gel,” April 2014,
  4. “Actinic Keratosis Treatment Options,” 2015,
  5. “Trends in Sunscreen Recommendation Among U.S. Physicians,” January 2014,

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