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New use of Aldara Cream
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::::: New use of Aldara cream to treat
Superficial Basal Cell Carcinoma, a Type of Skin Cancer :::::
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July 15th, 2004
FDA had approved a new indication for Aldara (imiquimod) topical cream. This product is currently approved for the treatment of actinic keratosis and external genital warts. Now, FDA is approving its use for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.
Superficial basal cell carcinoma is usually treated by surgical removal. Aldara should be used for treatment of sBCC only when surgery is medically less appropriate, because the chances of effectively treating sBCC are generally greater with surgery. Patients treated with Aldara for sBCC should have regular follow-up visits after treatment to make sure the skin cancer is completely treated.
The safety and effectiveness of Aldara were established in two double-blind controlled studies with approximately 364 patients. In these studies, 75% of patients (139/185) who had their sBCC treated with Aldara had no evidence clinically or on repeat biopsy of their sBCC at 12 weeks after finishing treatment. In a separate long-term study involving 182 patients, 79% of patients had no evidence of their sBCC at two years after finishing treatment.
Skin cancer can occur anywhere on the body, but it is most common on skin that has been exposed to sunlight. The most common type of skin cancer is basal cell carcinoma, affecting at least 800,000 Americans each year. The superficial type of basal cell carcinoma usually occurs on the arms, legs or on parts of the body such as the chest or back. Now FDA is approving Aldara for treatment of sBCC on the body, neck, arms or legs, but not for treatment of sBCC on the face.
Most patients using Aldara Cream for the treatment of sBCC experienced skin reactions at the treatment site, which include redness, swelling, a sore or blister, peeling, itching, and burning.
(Source: FDA)
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Posted on July 15, 2004 |
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