FDA OKs Skin Cream For Precancerous Spots
March 3, 2004 -- A new skin cream approved by the FDA may help
prevent common sun-related skin problems from developing into skin cancer.
The FDA today approved Aldara cream (5%), a topical
prescription cream for treating precancerous skin lesions that frequently occur
on the face and scalp of normal health adults. The rough, red, scaly patches or
crust on the skin known as actinic keratosis is caused by prolonged sun
exposure and affect about 10 million Americans each year.
AK lesions usually measure less than 1/4 inch in diameter and
more than 80% of lesions occur on the upper limbs, head, and neck. Fair skin
individuals with light hair and light-colored eyes are at greatest risk for AK.
Because AK is caused by cumulative sun exposure, it takes years to develop. The
condition usually appears first in older people, although it has been reported
in people in their 40s.
According to the cream's manufacturer, 3M Co., Aldara is the
first immune response modifier to be approved to treat actinic keratosis. The
cream works by stimulating the body's own immune system to fight off skin
Aldara Helps Prevent Skin Cancer
The FDA's approval of Aldara was based on a clinical trial
involving 436 people with multiple actinic keratosis skin lesions. Half of them
were treated with Aldara and half received a placebo twice a week for 16
The study showed that the lesions completely cleared up in
nearly half of the people treated with Aldara compared with only 3% of those on
the placebo. In addition, the majority of those who used Aldara experienced a
clearing of at least 75% or more.
The most commonly reported side effects included local skin
adverse skin reactions, such as flaking, scaling, dryness, scabbing, swelling,
and itching or burning at the application site.
Other available treatments for actinic keratosis include
freezing the lesion, surgically removing them, burning them off, laser
treatment, topical chemotherapy, and photodynamic therapy.
The company says the FDA is also considering another
application for Aldara in treating superficial basal cell carcinoma, a common
form of nonmelanoma skin cancer.