Long-term use of Aldara safe in AK patients

Skin & Allergy News,  April, 2005  by Patrice Wendling

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NEw ORLEANS -- There is a low incidence of new actinic keratoses after topical imiquimod 5% cream treatment, according to data from a long-term follow-up study.

No long-term safety issues or concerns with imiquimod (Aldara) 5% cream were seen in the observational study, Peter K. Lee, M.D., reported in a poster presentation at the annual meeting of the American Academy of Dermatology.

Likewise, no long-term adverse changes in skin quality were seen.

The follow-up study evaluated 146 of 177 patients with actinic keratosis (AK) who achieved complete clearance of their lesions in one of four large, phase III, randomized safety and efficacy trials conducted in the United States and Canada.

In the studies, patients applied imiquimod or vehicle to lesions on their faces or balding scalp either three times a week or twice a week for 16 weeks. Most of the patients had a Fitzpatrick skin type II or III, and all but one patient was white.

After a median follow-up of 16 months, 58 of the 77 patients (75%) treated with imiquimod three times a week, and 31 of 54 patients (57%) treated twice a week had no AK lesions in the previous treatment area.

Nineteen patients treated three times a week, 23 patients dosed twice weekly, and 7 of the 15 vehicle-treated patients had a recurrence, wrote Dr. Lee, who has received an honorarium and served as a consultant to Aldara's manufacturer, 3M Pharmaceuticals, which sponsored the study.

In patients who had a recurrence, the median number of lesions was one in both imiquimod treatment groups. The maximal number of lesions was five among the group treated three times a week and four among the twice-weekly group.

In contrast, patients had a median number of six lesions before treatment.

There was one adverse event at the follow-up visit that was considered possibly related to imiquimod. A patient treated twice a week had moderate hair loss on the eyebrow at the end of the phase III study; the loss had decreased to mild when the patient was seen 17 months later, according to Dr. Lee of the University of Minnesota, Minneapolis.

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