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