The 5% Imiquimod cream ( Aldara ) dosed 3 times weekly for 16 weeks is safe and effective for the treatment of actinic keratosis.
Two phase III randomized, vehicle-controlled studies evaluated the efficacy and safety of 5% Imiquimod cream compared with vehicle in the treatment of actinic keratosis.
A total of 492 patients, 18 years and older, with 4 to 8 actinic keratosis lesions in a 25-cm2 treatment area on the face or the balding scalp were randomised.
Patients applied 5% Imiquimod or vehicle cream to the treatment area once daily, 3 times per week, for 16 weeks.
The period of follow-up was of 8 weeks.
During 8-week post-treatment, complete and partial clearance rates for Imiquimod-treated patients ( 48.3% and 64.0%, respectively ) were clinically and statistically significantly higher than for vehicle-treated patients ( 7.2% and 13.6%, respectively ).
The median percentage reduction of baseline lesions was 86.6% for the Imiquimod-treated group and 14.3% for the vehicle-treated group.
According to the American Academy of Dermatology, actinic keratosis affects as many as 10 million Americans each year.
Caused by chronic sun exposure, actinic keratosis is a precancerous skin condition, which often occurs on the face and scalp. Actinic keratosis appears as rough, red, scaly patches or crusts on the skin.
Because actinic keratosis is caused by cumulative sun exposure, it can take years to develop.
The condition usually appears first in older people, although cases have been reported in people in their 40s.
Source: Archives of Dermatology, 2005