Aldara Cream To Treat Precancerous 'Sun Spots'
5 March 2004
ALDARA CREAM APPROVED TO TREAT PRECANCEROUS 'SUN SPOTS'
Aldara cream has been approved by the United States Food and Drug Administration (FDA, US regulatory body) to treat precancerous skin lesions.
The condition, actinic (solar) keratosis (more commonly known as "sun spots"), is caused by chronic sun exposure and affects tens of thousands of New Zealanders each year. These "sun spots" occur on the face and scalp and elsewhere as rough, scaly patches, or crusts on the skin.
The FDA approval of the topical cream Aldara as a treatment for "sun spots" follows clinical trials which found most patients experienced significant clearance of their lesions.1
While this approval is in the United States, New Zealand regulatory body Medsafe2 is also currently reviewing Aldara as an approved treatment here in New Zealand for both actinic (solar) keratosis and superficial basal cell carcinoma, the most common form of skin cancer.
Aldara, which is manufactured by 3M Pharmaceuticals, is the first cream to be approved that stimulates the body's own immune system for the treatment of these skin lesions.3
It is likely Aldara will provide a more effective and pain-free treatment option than current treatments which include freezing individual lesions, lasers and topical chemotherapy.
About 3M 3M is a diversified, international company based in St Paul, Minnesota, with the healthcare businesses consisting of more than 10,000 pharmaceutical, medical, surgical, consumer and home healthcare, and dental products. 3M is committed to supplying reliable products and services that make a difference in the practice, delivery and outcomes of healthcare. TM trademark AldaraTM is manufactured by 3M Health Care in Loughborough, United Kingdom For further information about 3M Pharmaceuticals, please visit www.mmm.com/pharma
1 Nearly half of the patients treated with Aldara cream achieved complete clearance of all lesions compared to only three percent in the placebo group. Most patients experienced lesion clearance of 75 percent of skin lesions in the treated area. The clinical studies also revealed another important feature of Aldara cream. Among patients treated with Aldara cream, a number of previously undetected lesions appeared and also cleared during treatment. The most frequently reported adverse reactions were local skin reactions but only 2 percent of patients reported pain at the treatment site.
2 Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.
3 Aldara is currently available in New Zealand as a patient applied treatment for genital warts. The drug stimulates the immune system to fight the underlying virus that causes the warts.