Topical skin creams effective to treat superficial basal cell carcinoma

In continuation of my update on imiquimod and fluorouracil

Basal cell carcinoma is one of the most common cancers and its incidence is increasing worldwide, putting a significant burden on health services. Topical treatments are available for superficial basal cell carcinoma (BCC) but there has a lack of long-term follow-up data to guide treatment decisions. A three-year randomized controlled clinical trial has found that two topical creams are effective in most primary, low-risk superficial BCC, comparing favorably with photodynamic therapy (PDT), as reported by investigators in the Journal of Investigative Dermatology.

More than 80% of all skin cancers are BCC, arising from the basal cells (i.e., small, round cells found in the lower layer of the epidermis). There are over two million cases a year in the U.S. and the lifetime risk of developing a BCC before the age of 85 years is one in five people. The prognosis is excellent, but it can cause significant disfigurement by invading surrounding tissues.

While most types of BCC require surgery, superficial BCC can be treated topically with noninvasive treatments such as PDT, imiquimod cream, fluorouracil cream, cryosurgery or electrodessication and curettage.

Investigators in the Netherlands report the results of a three-year follow-up of a randomized controlled trial that compared three noninvasive treatments that included imiquimod and fluorouracil cream. "The main advantages of noninvasive treatments are good cosmetic outcome, preservation of surrounding tissue, and potential for home application of either creams," explained lead investigator Marieke Roozeboom of the Department of Dermatology, Maastricht University Medical Center in the Netherlands. "Throughout the last two decades there has been a growing interest in these non-surgical therapies, which offer the possibility of avoiding surgery and reducing demands on busy medical practices."

However, prior to this study there has been a lack of randomized controlled trials with a long-term follow-up that compare the effectiveness of noninvasive treatments. Consequently, there is no consensus in international BCC guidelines on the first choice of noninvasive therapy for superficial BCC.

A total of 601 patients with a superficial BCC participated in this study: 202 patients were treated with methylaminolevulinate photodynamic therapy (MAL-PDT), 198 with imiquimod cream, and 201 with fluorouracil cream. The three study groups had a similar distribution of baseline characteristics, with the exception of tumor size.

Around 80% of patients with superficial BCC were tumor free after imiquimod treatment after three years. The clearance rate was 68% for patients treated with fluorouracil and 58% for individuals receiving PDT.

 imiquimod   fluorouracil

"Based on our findings, both imiquimod and fluorouracil are effective noninvasive treatments in most primary, low-risk superficial BCC, but the data provide no definite evidence for superiority of imiquimod to fluorouracil," commented Dr. Roozeboom. "Both creams have an equal cosmetic outcome and risk of local adverse events. Fluorouracil has the advantage of being less expensive than imiquimod. However, between one- and three-year follow-up, more recurrences were diagnosed in the fluorouracil group compared with the imiquimod group."

FDA approves Graceway Pharmaceuticals' NDA for Zyclara

We know that Imiquimod (structure - source -Drug Bank) is an   immune response modifier that acts as a toll-like receptor 7 agonist. Imiquimod is commonly used topically to treat warts on the skin of the genital and anal areas. Imiquimod does not cure warts, and new warts may appear during treatment. Imiquimod does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production.

Graceway® Pharmaceuticals announced recently  that, FDA has approved the New Drug Application (NDA) for Zyclara™, determining it to be safe and effective for the treatment of clinically typical, visible or palpable actinic keratoses (AK).   

The new treatment can be used on large areas of skin, including the full face or balding scalp on a convenient, 6-week dosing cycle.Zyclara shares the same active ingredient as Aldara® (imiquimod) Cream, 5% and while both topicals are FDA-approved for the treatment of AK, there are notable differences between the two.  

Zyclara is indicated for daily use on an accelerated 6-week dosing cycle comprised of two weeks of daily treatment with Zyclara, two weeks of non-treatment, followed by two weeks of daily treatment with Zyclara. Aldara is not approved for daily use and its approved dosing regimen is for a full 16 weeks.  Additionally, Zyclara is indicated for use on larger areas of skin, the full face or balding scalp, while Aldara is restricted to a 25 cm2 area of skin. 

"Because AKs are pre-cancerous and can develop on skin frequently exposed to the sun, such as the face or balding scalp, an effective treatment that can be used on large areas of skin is beneficial," said Darrell Rigel, M.D., clinical professor of dermatology, New York University Medical Center. ....

Ref : http://www.zyclaracream.com/

Vanillin could prevent or reduce psoriatic skin inflammation

Small amounts of artificial vanilla extract, also known as vanillin, are in a wide range of products, from baked goods to perfumes. But vanillin's versatility doesn't stop there. In a recent mouse study reported in ACS' Journal of Agricultural and Food Chemistry, researchers report that this compound could also prevent or reduce psoriatic skin inflammation.

Psoriasis is an inflammatory skin disorder that affects about 125 million people worldwide, resulting in scaly red plaques that typically show up on the elbows, knees or scalp. Immune system proteins called interleukins (IL) 17 and 23 are known to be key players in the development of the condition. Interestingly, vanillin can have effects on different interleukins that are involved in other inflammatory conditions and diseases. So, Chien-Yun Hsiang and Tin-Yun Ho wanted to see if treatment with vanillin could prevent psoriatic symptoms.

The researchers induced psoriatic skin inflammation on groups of mice by putting a compound called imiquimod on their skin. In addition, the mice were orally given daily doses (0, 1, 5, 10, 50 or 100 milligrams/kilograms of body weight) of vanillin for seven days. Mice treated with 50- or 100-milligram/kilograms of body weight doses had reduced psoriatic symptoms compared to those receiving smaller or no doses of vanillin. In all mice treated with vanillin, IL-17 and IL-23 protein levels were decreased. The researchers say that vanillin was an effective compound against psoriatic skin inflammation in this animal model.

Vanillin could prevent or reduce psoriatic skin inflammation