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.