A pharmaceutical treatment may offer patients
an alternative to the usual surgical removal of basal cell
carcinomas, according to a presentation at the annual meeting of the
American Academy of Dermatology in New Orleans. The results of a
pilot study show that imiquimod 5% cream (Aldara) is an effective
treatment for basal cell carcinoma.
Surgical treatments work well, but there should be a place for
medical treatments, and dermatologists need to be at the forefront in
using them, said lead investigator Karl Beutner, MD, PhD, of
Solano Dermatology Associates in Vallejo, California.
The study of 35 patients with basal cell carcinoma found that 100% of
patients who were treated either twice daily, once daily, or three
times per week with imiquimod cream experienced complete clearance of
the tumor after 10, 13, and 14.5 weeks of therapy, respectively.
Overall, taking into account all five arms of the trial, 83% of those
treated with imiquimod cream experienced complete clearance of the tumor.
Drug Stimulates Cytokine Production
Most current treatments for basal cell carcinoma involve surgical
removal, which causes scarring. Imiquimod uses the bodys own
immune system to fight disease and infection at the cellular level by
stimulating the production of cytokines, such as interferon-alpha.
The exact mechanism of action of imiquimod is unknown. It is
currently marketed as a topical treatment for external genital and
These results show great promise for imiquimod as a topical
treatment for basal cell carcinoma, especially on the extremities and
trunk, where scarring from surgery is more profound, said Dr.
Beutner. Products such as imiquimod can help physicians move
away from surgical approaches to medical treatments, which have the
potential to achieve better cosmetic results, he said.
About the Trial
The randomized, double-blind study compared the effects of imiquimod
cream with the effects of a placebo in 35 patients with a primary
basal cell carcinoma of defined size (median, 0.8 cm2) and confirmed
by biopsy to be either nodular or superficial.
A total of 24 patients received imiquimod cream and 11 received a
placebo cream in one of five dosing regimens: twice daily, once
daily, three times weekly, twice weekly, and once per week; all
regimens were continued for up to 2 weeks after visible clearance of
the tumor or for 16 weeks, whichever came first. After 6 weeks of
therapy, the treated sites were surgically removed and tested for
evidence of tumor.
All 15 of the patients in the twice-daily, once-daily, and
thrice-weekly dose groups achieved complete clearance of the basal
cell carcinoma. Complete tumor clearance was documented in 60% and
50% of the patients in the twice-weekly and once-weekly imiquimod
groups, respectively, and in 9% of the placebo group.
Although the results of the pilot trial are encouraging,
said Dr. Beutner, Large, well-controlled trials will be
necessary to confirm efficacy and establish optimal dosing regimens
for imiquimod before it can be used in more routine practice.
The study was supported by a grant from 3M Pharmaceuticals.