Almirall new data at EADO show positive results for Actikerall® application in the field-directed treatment of actinic keratosis.
- Phase III, randomised, double-blind, vehicle-controlled clinical trial evaluated the efficacy of Actikerall® (5-fluorouracil (5-FU) 0.5% / salicyclic acid 10%) when applied as actinic keratosis (AK) field-directed treatment
- Patients included in the study had a 25cm2 area of skin on their face, bald scalp or forehead that covered 4-10 clinically confirmed AK lesions (grade I/II)
- The main outcome was the rate of complete clinical clearance (CCC) at 8 weeks after end of treatment and it was found to be significantly higher with Actikerall® compared to vehicle (49.5% vs 18.2% respectively). These results are in line with previously reported efficacy rates for Actikerall® lesion-directed mode of application1
- Actikerall® is currently approved as a lesion-directed treatment with an option to simultaneously treat up to 10 AK lesions. The clinical trial aims to update the mode of administration and posology sections of the currently approved SmPC to include the field-directed treatment of a contiguous skin area of up to 25 cm2
Barcelona, September 5, 2016 – Almirall, S.A. (ALM), the global pharmaceutical company based in Barcelona, has announced positive results from a Phase III randomised, double-blind, vehicle-controlled study evaluating the efficacy and safety of Actikerall® (5-fluorouracil (5-FU) 0.5% / salicyclic acid 10%) when applied once daily as field-directed treatment to actinic keratosis (AK) lesions. Results have been presented at the 16th World Congress on Cancers of the Skin & 12th Congress of the European Association of Dermato Oncology (EADO).
Patients included in the study had a 25cm2 area of skin with 4-10 clinically confirmed AK lesions (grade I/II) either in their face, bald scalp or forehead. The trial met the primary efficacy endpoint with a significantly higher proportion of patients (49.5%) treated with Actikerall® achieving complete skin clearance at 8 weeks after the end of the treatment compared with vehicle (18.2%, p=0.0006).
Actikerall® once daily is an effective and unique topical treatment suitable for both lesion and field-directed treatment (up to 25 cm2) covering a broad range from mild-to-moderate even hyperkeratotic AK lesions.1,5,6
Field-directed therapies are primarily used to clear clinical as well as subclinical AK lesions. “A combination of both lesion and field-directed therapies is a mainstay in the control of AK which affects so many patients. AK lesions occur in sun-exposed areas as single lesions or/and affect an entire field of cancerization. The overall benefit-risk assessment is highly positive for field-directed treatment of actinic keratosis with Actikerall®”, commented Dr. Jordi Estruch, Global Medical Affairs Director at Almirall.
Secondary endpoints included partial clearance and percentage change from baseline in total number of AK lesions at 8 weeks after end of treatment. In this regard, the percentage of patients achieving partial clearance of AK lesions post-treatment with Actikerall® was significantly greater, approximately twice the one obtained with vehicle (69.5% vs. 34.6%; p<0.0001).
Additionally, the total number of lesions treated with Actikerall® decreased by 78% (47% with vehicle, p<0.0001) and the severity of the lesions decreased more with Actikerall® than with vehicle. These results were consistent with previously reported pivotal study results for lesion-directed treatment with Actikerall®.1
Safety outcomes were also assessed and were consistent with the known tolerability profile of Actikerall®.
“The prevalence of actinic keratosis is increasing worldwide and it is particularly prevalent after 60 years of age, there is growing evidence showing that even low grade lesions can become cancerous, so it is important to treat all AK lesions”, said Dr. Jordi Estruch. “These positive results confirm the potential of Actikerall® allowing further progresses in the treatment of AK”.
About actinic keratosis
Actinic keratosis or solar keratosis is a skin disease that manifests as spots or raised lesions of rough and squamous appearance in areas of the body exposed to the sun, which can be pink, red, brown or of the same color as the skin.2
Chronic sun exposure is the cause of almost all actinic keratosis. Sun damage to the skin is cumulative, so even a brief period in the sun adds to the lifetime total.1
Actinic keratosis, has been reported to affect approximately one out of three men over 70 years of age (18% of women), it is a precancerous skin disease caused by continued exposure to the sun, and some scientists interpret AK as the earliest form of squamous cell carcinoma.3
40-60% of squamous cell carcinomas begin as untreated actinic keratosis and may advance to invade the surrounding tissues. About 2 to 10% squamous cell carcinomas can spread to the internal organs and can become life-threatening.2
Actikerall® is a fixed combination of 5-Fluorouracil 0.5% (5 mg/g) and Salicylic Acid 10% (100 mg/g) in a film-forming base, taking advantage of both the anti-neoplastic, anti-metabolic activity of 5-FU and the keratolytic action of SA. Actikerall® is indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (grade I/II) in immunocompetent adult patients.4
Almirall is a global company based in Barcelona dedicated to providing valuable medicines and medical devices through its R&D, agreements and alliances. Our work covers the whole of the drug value chain. A consolidated growth allows us to devote our talent and efforts towards specialty areas and particularly to further grow as a leading Dermatology player. We are a specialist company, enabling us to accomplish the purpose of providing our innovative products wherever they are needed.
Founded in 1943, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision, and the commitment of its long-standing major shareholders. In 2015, Almirall revenues totalled 769 million euros and, with 1,800 employees, it has become a trusted presence across Europe, as well as in the US.
For more information, please visit www.almirall.com.
- Stockfleth E, Kerl H, Zwingers T, Willers C. Low-dose 5-fluorouracil in combination with salicylic acid as a new lesion-directed option to treat topically actinic keratoses: histological and clinical study results. Br J Dermatol. 2011;165(5):1101-8.
- Skincancer.org. (2016). Actinic Keratosis (AK) – SkinCancer.org. [online] Available at: http://www.skincancer.org/skin-cancer-information/actinic-keratosis [Accessed 10 Jun. 2016].
- Fartasch M, Diepgen T L, Schmitt J, Drexler H. The Relationship Between Occupational Sun Exposure and Non-Melanoma Skin Cancer: Clinical Basics, Epidemiology, Occupational Disease Evaluation, and Prevention. Dtsch Arztebl Int 2012; 109 (43): 715-20.
- Summary of Product Characteristics (SPC or SmPC)
- Stockfleth E, Zwingers T, Willers C. Recurrence rates and patient assessed outcomes of 0.5% 5-fluorouracil in combination with salicylic acid treating actinic keratoses. Eur J Dermatol. 2012;22(3):370-4
- Almirall SA. Multicentre, randomised, parallel, double-blind, vehicle controlled study to evaluate the efficacy and safety of Actikerall® solution in the field-directed treatment of actinic keratoses grade I to II (field cancerization). Clinical study report (Data on file). 2015
Cohn & Wolfe
Email: [email protected]
Email: [email protected]
Tel.: (+34) 91 531 5097