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 cancer.
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 weeks.
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.