FDA Approves Aldara Cream for Skin Cancer
Skin Cream Approved for Treating Superficial Basal Cell Carcinoma
July 20, 2004 -- Some people with a common form of skin cancer may now have an alternative to surgery for treatment of their disease.
The FDA has approved a new use for Aldara Cream for the treatment of superficial basal cell carcinoma when surgery is a less-appropriate treatment option.
Basal cell carcinoma is the most common type of skin cancer and affects about 800,000 people each year. Superficial basal cell carcinoma (sBCC) usually occurs on the arms, legs, chest, or back. Skin cancer can occur anywhere on the body but it's most common on skin that has been exposed to sunlight.
Superficial basal cell carcinoma is usually treated by surgical removal of the affected area. The FDA has approved Aldara Cream for the treatment of this condition only when surgery is medically less appropriate because the chances of effective treatment are greater with surgery.
People treated with Aldara should have regular follow-up visits after treatment to make sure their skin cancer is completely treated.
Aldara is already approved for the treatment of actinic keratosis (lesions on the skin caused by excessive sun exposure) and external genital warts.
Cream Approved for Skin Cancer
The FDA based its approval on the results of two double-blind controlled studies involving more than 300 people. The studies showed that 75% of people who had their skin cancer treated with Aldara had no evidence of skin cancer 12 weeks after finishing their treatment.
A long-term study with 182 patients showed that 79% of those treated with Aldara had no evidence of skin cancer two years after treatment.
The most common side effects associated with use of Aldara Cream for superficial basal cell carcinoma were at the treatment site, and include redness, swelling, a sore or blister, peeling, itching, and burning.
The FDA has approved Aldara for the treatment of superficial basal cell carcinoma on the body, neck, arms, or legs, but not for the treatment of this type of skin cancer on the face.
Aldara Cream is made by 3M Pharmaceuticals of St. Paul, Minn.