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Launch of first medical patch to treat early-stage non-melanoma skin cancer

by / Sunday, 22 November 2015 / Published in News

 

 

 

 

Launch of first medical patch to treat early-stage non-melanoma skin cancer (actinic keratosis)1

  • New report shows 1 in 4 people never check for signs of skin cancer, 1 in 5 rely solely on self-checking, and 1 in 14 (est. 165,000) avoid treatment due to previous bad experiences2
  • Also reveals GPs are provider of choice for 75% of Australians treated for actinic keratosis (AK / ‘sun-spots’)2
  • ALACARE® 5-ALA (5-aminolevulinic acid) is first medicated dermal patch treatment for AK with photodynamic therapy (PDT)1

Sydney, Australia – Australians are among the first in the world to gain access to the new dermal patch for the treatment of actinic keratosis, recognised as the earliest stages of potentially invasive squamous cell carcinoma (SCC).3
Available from today, ALACARE® 5-ALA dermal patch with photodynamic therapy (PDT) provides a precisely targeted and effective treatment for sun-spots with sustained clinical outcomes and cosmetic results that rated highly in trials.4,5

The Sun-spot Awareness Report reveals that 1 in 4 Australians (21%) aged 31 to 80 years still do not check for signs of skin cancer, because they ‘Never thought about it’ (46% of people who never check) or are ‘Not sure what to look for’ (29%).2 With a further 21% relying solely on self-checking, nearly half the population (46%) is at risk of missing skin cancer.2
As many as 40-60% of Australians – the highest rate in the world – will develop actinic keratosis after the age of 40.6 Up to 10% of AK lesions may progress to invasive SCC, which kills around 520 Australians per year.7,8

‘The vast majority of SCC deaths are preventable, and early identification and treatment of actinic keratosis, especially as the population ages, are critical to reduce the increasing social and economic burden of non-melanoma skin cancer in Australia,’ said Sydney dermatologist and skin cancer expert, Associate Professor Stephen Shumack. ‘It’s welcome news to have an additional treatment option available in this important area.’

The Sun-spot Awareness Report further shows that 21% of Australians have received treatment for AKs, mostly by GPs (75%), ahead of skin cancer clinics (49%) and dermatologists (27%).2 Only around half (48%) were given any options for treatment.2 Moreover, 7% (1 in 14) of those treated have had such a poor experience that they do not wish to return for future treatment.2 Extrapolating to the wider population, more than 165,000 Australians are placing their health in danger due to a previous poor treatment experience.

Non-melanoma skin cancer (largely basal cell carcinoma and squamous cell carcinoma) is the most expensive cancer in Australia.9 With no way of knowing which AKs will progress to SCC, Australian and international guidelines recommend all AKs be removed.6

A single dose of ALACARE® 5-ALA with PDT has been shown in global studies to eliminate up to 89% of AK lesions.4 In clinical trials, the cosmetic outcome from ALACARE® rated highly at follow-up consultations, and no evidence of change in pigmentation was seen at 12 months in the vast majority of people treated.5 ALACARE® 5-ALA with PDT does not require scraping of skin scale from the affected area (‘curettage’) prior to application and does not damage normal tissue surrounding the lesion.4

Associate Professor Peter Foley, Director of Research at the Skin and Cancer Foundation, commented: ‘While Australians are mostly well aware of the dangers of sun exposure, it’s clearly not always translating into behaviour in terms of regular skin checks, for a full quarter of the population. The role of the GP is critical, in educating patients about recognising AKs and seeking treatment promptly due to their potential to progress to an invasive NMSC.’

Is this a sun-spot?*
Less than half (45%) of those surveyed feel they could identify a sun-spot.2 When shown pictures of conditions that could be sun-spots, Australians struggle to distinguish them from: liver spots (seborrheic keratosis) (37% thought these were sun-spots), melanoma (36%), scar after cryotherapy (31%), basal cell carcinoma (31%) and a pimple (15%). The sun-spot was correctly identified 30% of the time – meaning that correct identification of sun-spots is no better than random chance.

Below are the images shown to Australians in the online research in October:

skin_cancer_images
* Download royalty-free high resolution images here:10
https://www.dropbox.com/sh/bvc9tn2zav58wdz/AAB0w3Q4oLHse57-Ywavo_GFa?dl=0

Please refer to ALACARE® Product Information before prescribing. Available at:
https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01490-1

MINIMIUM PRODUCT INFORMATION: ALACARE®

INDICATIONS Treatment of mild to moderate actinic keratoses (AK) lesions on the face and scalp
(hairless areas). CONTRAINDICATIONS Hypersensitivity to the active substance or to the patch material. No response to previous PDT with aminolevulinic acid containing preparations. Porphyria. PRECAUTIONS Very thick, red, scaly indurated AK lesions should not be treated with Alacare. Patients with moderate brown to black skin, and non-responders to previous PDT with aminolevulinic acid containing preparations. Discontinue any UV-therapy. Avoid sun exposure 48 hours following treatment. Avoid eye contact. Alacare should only be administered by a healthcare professional trained with the use of photodynamic therapies. Use in pregnancy (Category B2). Breast-feeding should be discontinued for 48 hours after treatment. Not recommended for children. INTERACTIONS Hypericin (St John’s Wort) should be discontinued two weeks before treatment. ADVERSE EFFECTS Erythema, exfoliation, irritation, pain, pruritus, scab, bleeding, desquamation, discharge, discomfort, erosion, hyper/hypopigmentation, oedema, reaction, swelling, vesicles, pustules, headache. DOSAGE AND ADMINISTRATION Apply a maximum of eight patches on eight different lesions on a single treatment session. Cover the lesions completely. After four hours, remove patch(s) and expose lesion(s) to red light (630 ± 3 nm) for a total light dose of 37 J/cm2. Lesion responses should be assessed after three months.

References:

Alacare Product Information. March 2015. Alacare is distributed by Link Healthcare Pty Ltd. ABN 73 010 971 516. 5 Apollo St, Warriewood, New South Wales 2102. Medical Information 1800 181 060.

Date of preparation: 11 May 2015.

PBS Information: This product is not listed on the PBS

– ENDS –

 

No compensation was provided to Professor Shumack or Professor Foley in relation to this Link Healthcare media announcement. The opinions expressed are their own. Professor Shumack and Professor Foley have been briefed by Link Healthcare on the approved use of this product.

 

 

NOTES TO THE EDITOR

About the Sun-spot Awareness Report
The Sun-spot Awareness Report represents the key findings of a permission-based online survey of 1,007 Australians nationally, conducted for the first time in October 2015 by Stollznow Research on behalf of Link Healthcare. Respondents were aged between 30 and 80 years of age, and comprised 49% women and 51% men. Quotas were set for location and age based on the 2011 Census (Australian Bureau of Statistics). For further key findings of the Sun-spot Awareness Report see backgrounder provided.

About ALACARE® 5-ALA (5-aminolevulinic acid) with photodynamic therapy (PDT):1
ALACARE® is indicated for the treatment of mild to moderate actinic keratoses (AK) lesions on the face and scalp (hairless areas). ALACARE® is a dermal patch consisting of a skin-tone backing foil and a self-adhesive matrix, covered by a release liner which is removed prior to application. Each patch measures 4cm2 and contains 8mg of 5-aminolevulinic acid (as hydrochloride). After topical application of aminolevulinic acid hydrochloride, protoporphyrin IX (PPIX) accumulates intracellularly in the treated AK lesion. The intracellular PPIX is a photoactive, fluorescing compound and, upon light activation in the presence of oxygen, singlet oxygen is formed which causes damage to cellular compartments of the light-exposed target cells, in particular the mitochondria.

About Link Healthcare:
Founded in Australia in 1997, Link Healthcare is focused on providing people with access to clinically important, specialised medicines and devices through strategic partnerships with leading biotechnology, pharmaceutical and medical technology companies around the world.

In September 2015, Clinigen acquired Link Healthcare strengthening the Group’s presence in Asia, Africa and Australasia and growing its global leadership position in the ethical supply of licensed and unlicensed medicines. Today, with group sales of more than AU$80M, Link Healthcare provides more than 100 proprietary and licensed products designed to enhance the wellbeing of people throughout the Region.

For more information visit: www.linkhealthcare.com.au or phone Medical Information on 1800 181 060. Link Healthcare Pty Ltd, ABN 73 010 971 516, 5 Apollo St, Warriewood NSW 2102.

References:
1. ALACARE® Approved Product Information March 2015: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2015-PI-01490-1&d=2015072416114622412
2. Sun-spot Awareness Report, October 2015. Conducted on behalf of Link Healthcare by Stollznow Research and Advisory 3. Dodd A, et al. Dermatol Ther (Heidelb) (2014) 4:11–31
4. Hauschild A. et al. British Journal of Dermatology 2009; 160 (pp. 1066-1074)
5. Szeimies R-M. British Journal of Dermatology, 2010; 160 pp. 410-414 6. See JA, et al. Aust J Dermatol. 2015. doi: 10.1111/ajd.12354 7. Fuchs A and Marmur E. Dermatol Surg. 2007, Sep 33(9):1099-101 8. AIHW (Online). Australian Cancer Incidence and Mortality books – Non-melanoma skin cancer, all types. (cited 2015 Sep 3. Available from: http://www.aihw.gov.au/acim-books/ 9. Fransen M, et al. MJA 2012, 197 (10) pp. 565-568 10. Getty Images: Medical Stock Photos

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