Clinical Trial Resource Center

FDA Approved Drugs » 1997
Medical Areas: Immunology | Infections and Infectious Diseases | Podiatry

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Aldara (imiquimod)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: 3M Pharmaceuticals
Approval Status: Approved March 1997
Treatment Area: external genital and perianal warts

General Information

Aldara is indicated for treatment of external genital and perianal warts in adults. Aldara is a vanishing cream applied by the patient and will be available by prescription only.

Clinical Results

In a clinical trial with 209 patients, 50% (72% females, 33% males) had wart clearance with Aldara cream after 16 weeks of therapy compared to 11% of vehicle group. Of those who cleared, 72% (n=39/54) of patients from the Aldara group and 82% (n=9/11) of the vehicle group remained wart clear after 12 weeks of follow-up. Aldara cream was generally well-tolerated. Most patients experienced a variety of local skin reactions; most experienced redness (61%) and some experienced erosion (30%) and flaking (20%), but these tended to be mild to moderate in intensity. Only 4% of clinical trial patients reported pain and less than 2% discontinued due to skin reactions.

Additional Information

Genital warts is a sexually transmitted disease (STD) caused by the human papilloma virus (HPV). HPV is one of the most common - and least talked about - of all STDs; at least 10 to 20 percent of sexually active Americans are thought to be infected. Genital warts is growing at a rate of 750,000 new cases each year, is spread by sexual contact with an infected partner and is highly contagious. This life long virus can cause warts in the genital and perianal areas in females and males. Male sexual partners of infected women often have HPV penile infection.

Genital warts may cause itching, burning, pain and tenderness. Although there is no cure for genital warts, treatment can alleviate physical symptoms and psychological reactions such as problems with sexuality, shame, embarrassment and self-blame.

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