Sections

Actinic Keratosis

Medication

Medication Summary

The goals of pharmacotherapy are to reduce morbidity and to prevent complications.

Class Summary

The drug of choice is topical 5-FU lotion or cream, which inhibits cell growth and proliferation.

Fluorouracil topical (Fluoroplex, Carac, Efudex, Tolak)

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Fluorouracil topical is used topically for the management of actinic keratoses. It interferes with DNA synthesis by blocking methylation of deoxyuridylic acid via inhibition of thymidylate synthetase and, subsequently, cell proliferation. For lesions on bald scalp or extremities, longer treatment is often necessary.

Ingenol mebutate topical (Picato)

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The precise mechanism by which ingenol mebutate causes cell death in actinic keratosis is unknown, but it may include a dual action of (1) rapid lesion necrosis by mitochondrial swelling and membrane disruption and (2) specific neutrophil-mediated, antibody-dependent cellular cytotoxicity by antibodies produced from B cells that bind to antigens on dysplastic epidermal cells.

The dosage for actinic keratosis differs depending on the application site. The 0.015% gel is used for application to the face or scalp for 3 consecutive days, whereas the 0.05% gel is used for application to the trunk or extremities for 2 consecutive days.

Class Summary

Investigation of imiquimod demonstrates it induces interferons alpha and gamma, TNF-alpha, and interleukin 12, among other cytokines. Studies using 5% cream in mice showed significant induction of interferon alpha at the site of application, occurring as early as 2 hours after treatment. At 4 hours after application, increases in interferon alpha mRNA levels were found, indicating an increase in transcription. Cytokine up-regulation is thought to be activated by imiquimod binding to toll-like receptor VII.

Imiquimod (Aldara 5% cream, Zyclara 3.75% cream)

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Imiquimod is an immune response modifier thought to produce a nonspecific anti–actinic keratosis response, interferon, natural killer cells, and a specific immune response (cytotoxic T cells). It is indicated for clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp.

Class Summary

Topical photosensitizing agents are administered in combination with PDT.

Aminolevulinic acid (Levulan Kerastick, Ameluz)

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This agent is a porphyrin precursor used in combination with narrow-band, red-light illumination for nonhyperkeratotic, nonpigmented actinic keratoses. When used with PDT, accumulation of photoactive porphyrins produces a photodynamic reaction that results in a cytotoxic process dependent upon the simultaneous presence of oxygen.

PDT with aminolevulinic acid is a 2-stage process involving application of the solution followed by illumination with blue light 14-18 hours later; treatment may be repeated every 8 weeks.

Topical solution 20% is intended for direct application to individual lesions diagnosed as actinic keratosis and not to perilesional skin. Application should involve either scalp or face lesions, but not both simultaneously. Recommended treatment frequency is 1 application and 1 dose of illumination per treatment site per 8-week treatment session. Each Levulan Kerastick should be used for only one patient.

Topical solution 10% is to be applied 1 mm thick to actinic keratosis and to approximately 5 mm of surrounding skin. Application area should not exceed 20 cm² and 2 g at one time. After covering with a light-blocking occlusive dressing for 3 hours, remove the dressing, wipe off the remaining gel, and follow with red light illumination.

Diclofenac transdermal gel (3%)

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Diclofenac topical is designated chemically as 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt, with an empirical formula of C₁₄ H₁₀ Cl₂ NO₂ Na. It is one of a series of phenylacetic acids that has demonstrated anti-inflammatory and analgesic properties in pharmacological studies. It is believed to inhibit the enzyme cyclooxygenase, which is essential in the biosynthesis of prostaglandins. Diclofenac topical can cause hepatotoxicity; hence, liver enzyme levels should be monitored in first 8 weeks of treatment.

It is used topically as a keratolytic agent to treat actinic keratoses.

Tirbanibulin topical (Klisyri)

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Tirbanibulin topical is a novel, first-in-class microtubule inhibitor that inhibits tubulin polymerization and Src kinase signalling. It is indicated for the topical treatment of actinic keratosis of the face or scalp.

Questions

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Fuchs A, Marmur E. The kinetics of skin cancer: progression of actinic keratosis to squamous cell carcinoma. Dermatol Surg. 2007 Sep. 33(9):1099-101. [QxMD MEDLINE Link].
Cockerell CJ. Histopathology of incipient intraepidermal squamous cell carcinoma ("actinic keratosis"). J Am Acad Dermatol. 2000 Jan. 42(1 Pt 2):11-7. [QxMD MEDLINE Link].
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Weissenborn SJ, Nindl I, Purdie K, et al. Human papillomavirus-DNA loads in actinic keratoses exceed those in non-melanoma skin cancers. J Invest Dermatol. 2005 Jul. 125(1):93-7. [QxMD MEDLINE Link].
McBride P, Neale R, Pandeya N, Green A. Sun-related factors, betapapillomavirus, and actinic keratoses: a prospective study. Arch Dermatol. 2007 Jul. 143(7):862-8. [QxMD MEDLINE Link].
Pfister H, Fuchs PG, Majewski S, Jablonska S, Pniewska I, Malejczyk M. High prevalence of epidermodysplasia verruciformis-associated human papillomavirus DNA in actinic keratoses of the immunocompetent population. Arch Dermatol Res. 2003 Dec. 295(7):273-9. [QxMD MEDLINE Link].
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Drake LA, Ceilley RI, Cornelison RL, et al. Guidelines of care for actinic keratoses. Committee on Guidelines of Care. J Am Acad Dermatol. 1995 Jan. 32(1):95-8. [QxMD MEDLINE Link].
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Moy RL. Clinical presentation of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan. 42(1 Pt 2):8-10. [QxMD MEDLINE Link].
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Thompson SC, Jolley D, Marks R. Reduction of solar keratoses by regular sunscreen use. N Engl J Med. 1993 Oct 14. 329(16):1147-51. [QxMD MEDLINE Link].
GlobeNewswire. Athenex announces FDA approval of Klisyri® (Tirbanibulin) for the treatment of actinic keratosis on the face or scalp. Available at https://www.globenewswire.com/news-release/2020/12/15/2145206/0/en/Athenex-Announces-FDA-Approval-of-Klisyri-Tirbanibulin-for-the-Treatment-of-Actinic-Keratosis-on-the-Face-or-Scalp.html. December 15, 2020; Accessed: January 11, 2021.
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Gupta AK, Davey V, Mcphail H. Evaluation of the effectiveness of imiquimod and 5-fluorouracil for the treatment of actinic keratosis: Critical review and meta-analysis of efficacy studies. J Cutan Med Surg. 2005 Oct. 9(5):209-14. [QxMD MEDLINE Link].
Loven K, Stein L, Furst K, Levy S. Evaluation of the efficacy and tolerability of 0.5% fluorouracil cream and 5% fluorouracil cream applied to each side of the face in patients with actinic keratosis. Clin Ther. 2002 Jun. 24(6):990-1000. [QxMD MEDLINE Link].
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Ulrich C, Bichel J, Euvrard S, et al. Topical immunomodulation under systemic immunosuppression: results of a multicentre, randomized, placebo-controlled safety and efficacy study of imiquimod 5% cream for the treatment of actinic keratoses in kidney, heart, and liver transplant patients. Br J Dermatol. 2007 Dec. 157 Suppl 2:25-31. [QxMD MEDLINE Link].
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Garbe C, Basset-Seguin N, Poulin Y, et al. Efficacy and safety of follow-up field treatment of actinic keratosis with ingenol mebutate 0·015% gel: a randomized, controlled 12-month study. Br J Dermatol. 2016 Mar. Vol 174(3):505-13. [QxMD MEDLINE Link].
Augustin M, Tu JH, Knudsen KM, Erntoft S, Larsson T, Hanke CW. Ingenol mebutate gel for actinic keratosis: the link between quality of life, treatment satisfaction, and clinical outcomes. J Am Acad Dermatol. 2015 May. Vol 72(5):816-21. [QxMD MEDLINE Link].
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[Guideline] Eisen DB, Asgari MM, Bennett DD, Connolly SM, Dellavalle RP, Freeman EE, et al. Guidelines of care for the management of actinic keratosis. J Am Acad Dermatol. 2021 Apr 2. [QxMD MEDLINE Link]. [Full Text].
Brunk D. AAD Unveils New Guidelines for Actinic Keratosis Management. Medscape Medical News. Available at https://www.medscape.com/viewarticle/950849. May 10, 2021; Accessed: June 3, 2021.

Media Gallery

Actinic keratosis. Courtesy of Hon Pak, MD.
Actinic keratosis during treatment with topical 5-fluorouracil. Courtesy of Hon Pak, MD.
Actinic keratosis right after treatment with topical 5-fluorouracil. Courtesy of Hon Pak, MD.
Erythematous, scaly lesions on the temple area, typical of actinic keratosis.

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Author

James M Spencer, MD Professor of Clinical Dermatology, Mount Sinai School of Medicine; Private Practice, Spencer Dermatology

James M Spencer, MD is a member of the following medical societies: American Academy of Cosmetic Surgery, American Academy of Dermatology, American College of Mohs Surgery, American Medical Association, American Society for Dermatologic Surgery, American Society for Laser Medicine and Surgery, International Society for Dermatologic Surgery

Disclosure: Received grant/research funds from Genentech for independent contractor; Received grant/research funds from DUSA for independent contractor; Received honoraria from Leo Pharmicuticals for review panel membership.

Coauthor(s)

Laura Jordan, DO, MA, MS, MLS Dermatology-Focus Traditional Rotating Intern, UH Regional Hospitals

Laura Jordan, DO, MA, MS, MLS is a member of the following medical societies: American Osteopathic College of Dermatology

Disclosure: Nothing to disclose.

Specialty Editor Board

Michael J Wells, MD, FAAD Dermatologic/Mohs Surgeon, The Surgery Center at Plano Dermatology

Michael J Wells, MD, FAAD is a member of the following medical societies: Alpha Omega Alpha, American Academy of Dermatology, American Medical Association, Texas Medical Association

Disclosure: Nothing to disclose.

Chief Editor

William D James, MD Paul R Gross Professor of Dermatology, Vice-Chairman, Residency Program Director, Department of Dermatology, University of Pennsylvania School of Medicine

William D James, MD is a member of the following medical societies: American Academy of Dermatology, Society for Investigative Dermatology

Disclosure: Received income in an amount equal to or greater than $250 from: Elsevier; WebMD<br/>Served as a speaker for various universities, dermatology societies, and dermatology departments.

Additional Contributors

Kelly M Cordoro, MD Assistant Professor of Clinical Dermatology and Pediatrics, Department of Dermatology, University of California, San Francisco School of Medicine

Kelly M Cordoro, MD is a member of the following medical societies: Alpha Omega Alpha, American Academy of Dermatology, American Medical Association, Medical Society of Virginia, Society for Pediatric Dermatology, Women's Dermatologic Society, Association of Professors of Dermatology, National Psoriasis Foundation, Dermatology Foundation

Disclosure: Nothing to disclose.

Michelle Henry, MD Fellow in Procedural Dermatology, Department of Dermatology, Lahey Clinic, Harvard Medical School

Disclosure: Nothing to disclose.

Acknowledgements

Amy Lynn Basile, DO, MPH Sun Coast Hospital/Largo Medical Center, Largo, Florida

Disclosure: Nothing to disclose.

Mary Farley, MD Dermatologic Surgeon/Mohs Surgeon, Anne Arundel Surgery Center

Disclosure: Nothing to disclose.

James Fulton Jr, MD, PhD Medical Director, Fulton Skin Institute

Disclosure: Nothing to disclose.

Actinic Keratosis Medication

Medication Summary

Antineoplastic Agent, Topical

Class Summary

Fluorouracil topical (Fluoroplex, Carac, Efudex, Tolak)