Drugs Xagena
The FDA ( U.S. Food and Drug Administration ) has approved Zyclara ( Imiquimod ), a new topical cream for actinic keratoses ( AK ) on the face or balding scalp.
Clinical studies have proved Zyclara to be safe and effective for the treatment of clinically typical visible or palpable actinic keratoses.
It is estimated that about 10 million Americans have actinic keratose, a common pre-cancerous lesion that often develops on skin frequently exposed to the sun.
People that have one actinic keratose will likely develop more cancer over their lifetime.
In Zyclara clinical trials, patients had five to 20 actinic keratoses on their face or scalp at the start of the study.
Treatment with Zyclara has reduced the total number of actinic keratoses by 82%. The treatment performed better than placebo across two key study measures: 36% of patients experienced complete clearance of all actinic keratoses, meaning zero actinic keratoses after treatment. Partial clearance, defined as a 75% reduction or higher in actinic keratose totals, was achieved by 59% of patients.
If there are actinic keratoses visible on the surface of the skin, it is likely that there are more actinic keratoses just below the skin's surface. Zyclara revealed these actinic keratoses in 86% of patients. In the study, Zyclara treated both types of actinic keratoses -- those found at the start of the study and those unmasked during treatment. Additionally, over 40% of the physicians reported Zyclara has significantly improved the appearance of patients' skin.
Zyclara is believed to work by activating the skin's immune system to treat actinic keratose. The topical cream comes in small, easy-to-use, packets that are applied once nightly before bed on a two-week treatment cycle. Two 2-week treatment cycles coupled with a 2-week treatment holiday represent the total course of therapy.
In the double-blind, placebo-controlled studies, 319 adults with five to 20 actinic keratose lesions in a treatment area ( full face or balding scalp ) were randomized to either placebo or Zyclara. Patients applied up to 500 mg of cream once daily for two, two-week treatment cycles, separated by a two-week non-treatment period. Primary efficacy was assessed eight weeks after the last dose.
Local skin reactions, such as redness, are consistent with treatment response. The most commonly reported severe local skin reactions were redness ( 25% ), scabbing or crusting ( 14% ), sore or ulcer ( 11% ), and flaking, scaling or dryness ( 8% ).
Actinic keratose is a sign of sun damage resulting from long-term exposure to harmful UV rays. The sun's rays cause changes in the size, shape, and organization of the top layer of skin cells, also known as the epidermis, and just below it. These cellular mutations can then form actinic keratoses.
Actinic keratose is considered a pre-cancer and is often confused with age spots, eczema or psoriasis. Actinic keratoses are small, red, sometimes scaly or rough patches that can be found on skin most often exposed to the sun like the face, bald scalp, hands, shoulders and arms.
Actinic keratoses can vary in shape and color, ranging from red to light or dark tan, pink, or a combination of these. These lesions may range from the size of a pinhead to larger than a quarter and may feel dry and rough like sandpaper. In the beginning, actinic keratoses can be so small that they are often identified by their rough texture rather than by sight.
Some actinic keratoses will develop into a serious form of skin cancer called squamous cell carcinoma, or SCC. If left unchecked, this cancer can spread to other areas of the body and organs. ( Xagena )
Fonte: Graceway Pharmaceutical, 2010
XagenaMedicine_2010
