Health Canada approves Zyclara Cream for multiple actinic keratoses

Jan 6 2010

Health Canada has approved Zyclara™ (imiquimod) Cream 3.75%, a topical prescription treatment for multiple actinic keratoses (AK) located on the face or balding scalp in adults. Actinic Keratosis is a common skin condition that can lead to squamous cell carcinoma, a form of non-melanoma skin cancer, if left untreated.

“With a shortened course of therapy compared with other prescription creams, Zyclara offers a more simplified treatment regimen which encourages patient compliance”

Actinic keratosis is a precancerous skin condition which can be caused by chronic sun exposure. AK can affect Canadians all year round, and can even manifest in the winter months.

Zyclara Cream is an immune response modifier. This means it works by stimulating the body’s own immune system to recognize and respond to clear AK lesions safely and effectively.

“Zyclara is a safe and effective new option that has many benefits over and above existing treatments,“ said Jefferson J. Gregory, Chairman and CEO of Graceway Pharmaceuticals, LLC. “Zyclara targets visible lesions but also clears sub-clinical lesions that exist beneath the surface of the skin, it’s easy to use and can be applied at home, and unlike other treatment options, it can be used on a large surface area.”

In two double-blind, randomized, placebo-controlled clinical studies, 319 subjects with AK lesions were treated with Zyclara Cream, or a matching placebo cream once daily for two, two-week cycles with a two-week non-treatment period in between. The study found that 35.6 per cent of patients treated with Zyclara Cream had a complete clearance of all lesions compared to only 6.3 per cent in the placebo group. The majority of patients treated with Zyclara Cream experienced a lesion reduction of 81.8 per cent.

Studies also showed Zyclara Cream can be used on a large surface area and not only targets visible lesions, but also clears lesions that are not yet visible but exist beneath the surface of the skin.

“With a shortened course of therapy compared with other prescription creams, Zyclara offers a more simplified treatment regimen which encourages patient compliance,” said Mr. Gregory. “And as a non-invasive therapy, it offers patients a comfortable treatment experience, while still addressing both cosmetic and medical concerns.”

Zylcara Cream is applied by the patient at home in a short course of therapy. It is used once daily, applied at bedtime to the skin of the affected area. Treatment duration is two weeks on, two weeks off, two weeks on, unless otherwise directed by a physician.

In clinical trials, Zyclara Cream was generally well tolerated. The majority of local skin reactions were mild to moderate. The most common side effects included headache, application site pruritus (itching) and irritation, fatigue and nausea.

In addition to imiquimod cream (3.75% and 5%), other treatment options include cryotherapy (freezing), excisional surgery, curettage (scraping), electrodessication (drying), lasers (burning), and topical chemotherapy.

Zyclara Cream is available only by prescription.