Related Pages Skin Cancer Home Page 1 NCI's gateway for information about skin cancer. Drug Information Summaries 2 NCI's drug information summaries provide consumer-friendly information about certain drugs that are approved by the U.S. Food and Drug Administration (FDA) to treat cancer or conditions related to cancer.

Brand name(s): Aldara®

• Approved for superficial basal cell carcinoma

Full prescribing information ³ is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

This type of skin cancer is diagnosed by a healthcare provider after biopsy and is different from other types of skin cancer including other types of basal cell carcinoma.

Superficial basal cell carcinoma is usually treated by surgical removal. Imiquimod 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 imiquimod for sBCC should have regular follow-up visits after treatment to make sure the skin cancer is completely treated.

The safety and effectiveness of imiquimod were established in two double-blind controlled studies with approximately 364 patients. In these studies, 75 percent of patients (139/185) who had their sBCC treated with imiquimod 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 percent 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 imiquimod for treatment of sBCC on the body, neck, arms or legs, but not for treatment of sBCC on the face.

Most patients using imiquimod for the treatment of sBCC experienced skin reactions at the treatment site, which include redness, swelling, a sore or blister, peeling, itching, and burning.

Glossary Terms

The removal of cells or tissues for examination by a pathologist. The pathologist may study the tissue under a microscope or perform other tests on the cells or tissue. There are many different types of biopsy procedures. The most common types include: (1) incisional biopsy, in which only a sample of tissue is removed; (2) excisional biopsy, in which an entire lump or suspicious area is removed; and (3) needle biopsy, in which a sample of tissue or fluid is removed with a needle. When a wide needle is used, the procedure is called a core biopsy. When a thin needle is used, the procedure is called a fine-needle aspiration biopsy.

A clinical study that includes a comparison (control) group. The comparison group receives a placebo, another treatment, or no treatment at all.

In medicine, a sign, symptom, or medical condition that leads to the recommendation of a treatment, test, or procedure.