{"id":327592,"date":"2021-10-21T14:00:00","date_gmt":"2021-10-21T12:00:00","guid":{"rendered":"https:\/\/medizinonline.com\/topical-treatment-options-an-update\/"},"modified":"2021-10-21T14:00:00","modified_gmt":"2021-10-21T12:00:00","slug":"topical-treatment-options-an-update","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/topical-treatment-options-an-update\/","title":{"rendered":"Topical treatment options – an update"},"content":{"rendered":"

Actinic keratoses are the most common dermatoses on chronically sun-damaged skin, especially in people with fair skin types. Prevalence increases significantly from the sixth decade of life. The spectrum of lesion-targeted therapies has recently expanded to include a topical treatment option – a novel agent inhibits tubulin polymerization, thereby arresting the cell cycle. In field treatment, a 4% 5-fluorouracil cream has been shown to be comparably effective to the 5% preparation.<\/strong><\/p>\n

<\/p>\n

Actinic keratoses are defined as intraepidermal proliferation of atypical keratinocytes on UV-damaged skin with the potential to progress into invasive cutaneous squamous cell carcinoma [1]. Predilection sites are face, ears and scalp. In European countries, the prevalence in those over 60 years of age is between 20-35% . The UV-induced lesions of actinic keratosis develop into rough, keratinized, and scaly patches that may be skin-colored or red. Even though they are usually benign: in up to 16% of cases they can develop into squamous cell carcinoma, which is the second most common malignant epithelial skin tumor after basal cell carcinoma [4,5]. Regarding risk of progression, a multilevel scaling has been proposed to describe the transition from actinic keratosis (AK) to squamous cell carcinoma (PEK) (Box<\/span> ) [6].<\/p>\n

Prof. Dr. med. Thomas Dirschka, CentroDerm, Wuppertal (D), gave an up-to-date overview of treatment options for actinic keratosis on the occasion of this year’s annual congress of the Arbeitsgemeinschaft Dermatologische Onkologie (ADO) [7].<\/p>\n

5-fluorouracil: lower-dose preparation with comparable efficacy<\/h2>\n

In addition to Efudix cream 5%, Tolak\u00ae cream 4%, a new topical preparation containing 40 mg\/g 5-fluorouracil (5-FU), is available* [7]. This has added another therapeutic option to the spectrum of therapeutic alternatives to field treatment. Despite lower dosage, Tolak\u00ae showed comparable efficacy. “It can be used in all locations and the maximum applicability is 500 cm2, so this is really something for large areas,” said Prof. Dirschka [7]. In a multicenter, double-blind, vehicle-controlled study (n=841), once-daily use of 5-FU 4% cream was compared with twice-daily use of 5-FU 5% cream and vehicle [8]. After four weeks, the two treatment groups showed comparable response: 80.5% of patients with 4% 5-FU versus 80.2% of patients with 5% 5-FU had 75% fewer lesions. Therapy with the 40 mg\/g cream was used only 1\u00d7 daily, and the 5% 5-FU cream was used 2\u00d7 daily. The new, lower-dose formulation thus showed a comparable healing rate to the previous standard therapy with only 1\u00d7 daily application. Optimized tolerability with less severe skin reactions was associated with a lower rate of treatment discontinuation (10.1% for 4% 5-FU vs. 14.9% for 5% 5-FU) [8].<\/p>\n

* Tolak\u00ae: Swissmedic approval 02.03.2021 [12]<\/em><\/span><\/p>\n

 <\/h2>\n\n\n\n
\n

Risk of progression of actinic lesions<\/strong><\/p>\n

The progressive stages of keratinocytic intraepidermal neoplasia (KIN) have been classified into three stages [6]. In KIN I, atypical keratinocytes are found in the lower third of the epidermis. This stage may develop into lesions that cover the lower two-thirds of the epidermis (KIN II) and subsequently cover the full thickness of the epidermis (KIN III). In a paper published in JEADV, actinic keratoses (AK) were classified as premalignant and\/or precancerous, with only KIN III\/AK III considered in situ squamous cell carcinoma [10]. The absolute risk of head AK lesion developing into squamous cell carcinoma within 16-34 months is reported to be 0.42 [11].<\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/h2>\n

Tirbanibulin: significant reduction in “lesion count” with little irritation.<\/h2>\n

The mode of action of tirbanibulin (Klisyri\u00ae), an inhibitor of tubulin polymerization, is based on blockade of the intracellular protein tyrosine kinase Src, which is increasingly expressed in AK and plays a role in progression to PEK [1]. The preparation with the novel active substance is applied 1\u00d7 daily for 5 days, to max. 25 cm2 skin area. The EMA approval** is based on the results of two double-blind, vehicle-controlled Phase III studies [9]. Subjects (n=702) applied either tirbanibulin ointment 1% (10 mg\/g) or a vehicle preparation to lesions on the face or scalp on five days. Two parallel studies were conducted. Complete healing at day 57 was achieved by 44% of tirbanibulin-treated patients in one study versus 5% in the vehicle-treated group (p<0.001). In the second study, complete clearance was observed in 54% vs. 13% of patients (p<0.001). In addition to the primary endpoint, the main secondary endpoint was also met: significantly more patients achieved 75% healing 57 days after baseline under verum treatment than in the control group: 68% vs. 16% (p<0.001) in the first study and 76% vs. 20% (p<0.001) in the second study, respectively [9]. In summary, tirbanibulin not only showed a significant reduction in the number of lesions, but also convinced with a low extent of side effects.<\/p>\n

** Tirbanibulin: Swissmedic new registration 14.01.2021 [13]<\/span><\/em><\/p>\n

 <\/p>\n

Congress: Working Group of Dermatologic Oncology (ADO)<\/em><\/p>\n

 <\/p>\n

Literature:<\/p>\n

    \n
  1. Borik-Heil L, Geusau A: hautnah 2021; 20: 45-55.<\/li>\n
  2. Ferr\u00e1ndiz C, et al: Actas Dermosifiliogr 2016; 107(8): 674-680.<\/li>\n
  3. Eder J, et al: Br J Derm 2014; 171(6): 1415-1421.<\/li>\n
  4. Stockfleth E: JEADV 2017; 31 (2): 8-11.<\/li>\n
  5. Trautinger F, Beichl-Zwiauer V: \u00d6sterreichische \u00c4rztezeitung 13\/14, July 15, 2021 (online), (last accessed Sept. 19, 2021).<\/li>\n
  6. AWMF: S3-Leitlinie: Aktinische Keratose und Plattenepithelkarzinom der Haut. 2020. www.awmf.org, (last accessed 19.09.2021)<\/li>\n
  7. Dirschka T: Non-melanocytic skin tumors – Current status in diagnostics and therapy of actinic keratosis, Prof. Dr. med. Thomas Dirschka, German Skin Cancer Congress, 08.-11.09.2021.<\/li>\n
  8. Dohill MA: J Drugs Dermatol 2016; 15 (10): 1218-1224.<\/li>\n
  9. Blauvelt A, et al: N Engl J Med 2021; 384: 512-520.<\/li>\n
  10. Fernandez-Figueras MT, et al: JEADV 2015; 29(5): 991-997.<\/li>\n
  11. Smit P, et al: JEADV 2013; 27(6): 667-671.<\/li>\n
  12. Swissmedic Journal 03\/2021, www.swissmedic.ch, (last accessed Sept. 19, 2021).<\/li>\n
  13. Swissmedic Journal 01\/2021, www.swissmedic.ch, (last accessed Sept. 19, 2021).<\/li>\n<\/ol>\n

     <\/p>\n

    DERMATOLOGY PRACTICE 2021; 31(5): 50<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Actinic keratoses are the most common dermatoses on chronically sun-damaged skin, especially in people with fair skin types. Prevalence increases significantly from the sixth decade of life. The spectrum of lesion-targeted…<\/p>\n","protected":false},"author":7,"featured_media":112416,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Actinic keratoses","footnotes":""},"category":[11513,11340,11370,11548,11503],"tags":[18941,13587,18952,18982,18961,18964,18975,18956,18021,18988,14239,12530,18970,18946],"powerkit_post_featured":[],"class_list":["post-327592","post","type-post","status-publish","format-standard","has-post-thumbnail","category-congress-reports","category-dermatology-and-venereology","category-oncology","category-rx-en","category-studies","tag-5-fu-en","tag-actinic-keratosis","tag-ado-en","tag-efudix-en","tag-field-treatment","tag-fluorouracil-en","tag-klisyri-en","tag-lesion-directed","tag-tirbanibulin-en","tag-tolak-en","tag-topical","tag-treatment","tag-tubulin-polymerization","tag-working-group-dermatologic-oncology","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-04-25 07:06:54","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":327614,"slug":"options-de-traitement-topique-une-mise-a-jour","post_title":"Options de traitement topique - une mise \u00e0 jour","href":"https:\/\/medizinonline.com\/fr\/options-de-traitement-topique-une-mise-a-jour\/"},"it_IT":{"locale":"it_IT","id":327625,"slug":"opzioni-di-trattamento-topico-un-aggiornamento","post_title":"Opzioni di trattamento topico - un aggiornamento","href":"https:\/\/medizinonline.com\/it\/opzioni-di-trattamento-topico-un-aggiornamento\/"},"pt_PT":{"locale":"pt_PT","id":327630,"slug":"opcoes-de-tratamento-topico-uma-actualizacao","post_title":"Op\u00e7\u00f5es de tratamento t\u00f3pico - uma actualiza\u00e7\u00e3o","href":"https:\/\/medizinonline.com\/pt-pt\/opcoes-de-tratamento-topico-uma-actualizacao\/"},"es_ES":{"locale":"es_ES","id":327638,"slug":"opciones-de-tratamiento-topico-una-actualizacion","post_title":"Opciones de tratamiento t\u00f3pico - una actualizaci\u00f3n","href":"https:\/\/medizinonline.com\/es\/opciones-de-tratamiento-topico-una-actualizacion\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/327592","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=327592"}],"version-history":[{"count":0,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/327592\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/112416"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=327592"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=327592"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=327592"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=327592"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}