Zyclara 3.75% more effective than cryotherapy alone in treatment of Actinic Keratoses: Study

Sep 30 2010

Results from a randomized, double-blinded, placebo-controlled, multicentred study just published in the Journal of Drugs in Dermatology shows that treating Actinic Keratoses (AK) with imiquimod 3.75% (Zyclara^®) following cryotherapy was more effective than cryotherapy alone in reducing total AK lesion count and achieving complete clearance of AK. The study found that cryotherapy followed by imiquimod 3.75% (Zyclara^®) produced greater lesion reduction across all measures including doubling the proportion of patients with sustained complete clearance from 30 per cent to 60 per cent in the cryotherapy-treated area.

Cryosurgery is the most commonly used treatment for AK patients, with studies finding that more than 75 percent of patients with AK are treated only with cryosurgery. However, a limitation of cryotherapy is that it can only be used to treat visible AK lesions. To further research the clinical utility of a more comprehensive treatment strategy, the study evaluated the safety and efficacy of employing a field-directed treatment that could be used across the full face (Zyclara^®) in a patient population with extensive disease following a lesion-directed treatment (cryosurgery). 

These study results demonstrate that combining the two treatment modalities provides additional therapeutic benefits to cryotherapy alone.

"The results of this study are relevant because they could mean a change in the way AK is managed, providing physicians a combination therapy that targets AK lesions in two distinct ways," said Dr. Marc Bourcier, study author and Assistant Professor in clinical teaching, Faculty of Medicine, Sherbrooke University. "Visible lesions only are treated with cryotherapy, while multiple lesions and those AK's below the skin's surface are treated using Zyclara^® to get at the underlying disease. The combination therapy not only enhances the efficacy of cryotherapy to reduce the number of lesions, but it also promotes sustained clearance."

Actinic Keratoses are considered to be the earliest stage in the development of skin cancer and have the potential, if left untreated, to progress to squamous cell carcinoma (SCC), the second most common form of non-melanoma skin cancer.  Not long ago in December 2009, Health Canada approved Zyclara^®, a topical cream for the treatment of multiple AKs located on the face or balding scalp in adults. In a short course of therapy, Zyclara^® is used once daily for up to two weeks, then off for two weeks, and two weeks back on, unless otherwise directed. 

"This study adds to the growing body of evidence to support the efficacy and safety of Zyclara^® for field treatment," said Dr. Bourcier. "Also, with a shortened course of therapy, Zyclara^® offers a more simplified treatment regimen than imiquimod 5% and is also now an effective, safe and non-invasive complement to cryotherapy."