An update of news and treatment trends.

Patient-Friendly Digital Dermoscopy

Patients concerned about skin cancer — especially after noticing a suspicious growth — may gain peace of mind or next-steps information by undergoing a MoleSafe body scan, which consumer-directed product information from the company calls “a powerful tool to assist you and your physician to provide the highest quality of care currently available in managing your melanoma risk.”

The painless, noninvasive procedure is now offered in six U.S. locations by the New Zealand-based company MoleSafe. The scan takes about 1 hour and uses digital dermoscopy imaging to create a complete record of the skin and lesions down to the microscopic level. Images are then viewed via teledermoscopy and interpreted by what company literature terms “a panel of expert melanoma dermatologists,” and the patient is provided with a written report to help guide care.

The Technology

MoleSafe’s digital dermoscopy technology combines high-light intensity with high magnification to illuminate sub-surface features of the skin, permitting doctors to see features that cannot be detected by the naked eye, including clinically featureless melanomas that look like normal moles. The technology also reduces the need to unnecessarily biopsy benign lesions.

How it Works
Patients may come on their own or by referral for the screening procedure for which there is not yet widespread insurance coverage, although some insurance companies may cover a portion of the screening costs.

After the patient profile has been established and patients change into a gown, a nurse trained in dermoscopy uses MoleSafe’s digital dermoscopy cameras to take a whole body image of the patient’s skin, which serves as a baseline record of the skin for future comparisons to help identify any changes or new moles.

While the procedure typically takes about an hour, an extended visit or second appointment may be required where there are a large number of moles to image. A range of follow-up appointments are available for spot checks and full re-imaging.

Follow-up

A copy of the findings are sent to the patient as well as physician. The patient copy, which should be received within 10 working days, outlines results and offers a recommendation as to when the next assessment should be scheduled; it also provides general advice about sun protection and early detection. However, if a suspicious lesion is identified, the patient is instructed to contact a dermatologist immediately to schedule an appointment to determine and arrange for required treatment.

A Growing Company

MoleSafe has conducted more than 135,000 examinations on 75,000 patients, imaged and diagnosed more than 1.5 million lesions, identifying close to 1,500 melanomas. While there have not yet been community screening days, the company claims their equipment could be used in a mobile setting.

European Regulators Recommend Approval of Actikerall for Actinic Keratosis Treatment

A ccording to a press release from Almirall, S.A., the regulatory authorities in Germany, UK, Austria, Luxemburg, Poland, Czech Republic and Slovakia have granted a positive recommendation for the regulatory approval of Actikerall (5 mg/g flourouracil and 100 mg/g salicylic acid) for the treatment of palpable and/or moderately thick hyperkeratotic actinic keratosis, including grade I and grade II, in adult patients.

Actikerall is a topical solution for lesion-directed treatment against hyperkeratotic actinic keratoses and has, according to the Almirall release, shown good clinical efficacy data confirmed by histological clearance of lesions in 72.0% of patients after treatment and sustained clinical benefit of 85.8% lesion clearance 12 months after treatment. The tolerability profile was said to be good, with only site application events of mild to moderate intensity reported.

The regulatory process will now enter its national phase to finalize product packaging and related documents, after which national marketing approvals can be granted in each of the respective countries.

First launches are expected in the Germany and UK in mid 2011. N

Avobenzone Stability and UV Damage Repair Research by Avon is Basis of New Product Line

Two studies presented as posters by Avon Products at the winter American Academy of Dermatology meeting documented the company’s efforts to explore innovative ways to optimize the stability and thereby to help extend the protection capabilities of avobenzone, an established UVA absorber and the ingredient most commonly used in broad-spectrum sun protection products sold in the United States. Both studies were sponsored by Global R & D, Avon Products, Inc., and provided the basis for a new product line.

In Photostability of Sunscreen Combinations Containing Avobenzone Exposed to Natural and Artificial UV Light (P1012), Anthony D. Gonzalez and Faith A. Gaenzler PhD, reported that combining two cosmetic skin conditioning agents — galangal extract and polyester-8 with model sunscreen systems containing avobenzone — improves the photostability of avobenzone, which can undergo molecular changes during extensive sun exposure that affect its protective properties.

In Mechanisms to Protect Skin Cells from UV Damage (P3115), Raaj Khusial, Jennifer DeLapa and Uma Santhanam, examined new ways to enhance the repair of UV-induced damage and to identify new mechanisms of protection against UV damage. They identified a blend of phytochemicals and extracts that helped facilitate the reduction of UV-induced sun damage in skin cells by 50% in 24 hours, indicating the enhancement of the skin's natural repair process. Study findings on skin cells also suggested that these ingredients can help stimulate the skin’s own anti-oxidant enzymes and lower oxidative stress, thus creating an optimal environment for cell recovery.

As a result of findings from these two studies, the company developed the ANEW Solar Advance anti-aging sun care line, which the company claims is able to provide superior protection against the sun’s damaging rays with photostable broad-spectrum UVA/UVB protection and can repair skin cell sun damage by stimulating the skin’s natural antioxidant defense system to fight free radicals and to repair by activating skin’s natural repair process.

Sun Protection in a Pill?

Sunscreen is an important part of sun protection, but it’s not complete protection. There are currently no FDA measurements for UVA protection, so patients may not be getting all the protection they need, as many patients do not apply sunscreen properly, and many also forget to reapply as often as they should. To help patients get complete protection, some dermatologists are recommending patients take a Heliocare capsule daily. Heliocare, according to manufacturer Biopelle, Inc., offers a form of oral sun protection providing systemic defense from the sun’s damaging rays. Each capsule contains 240 mg of Fernblock (Polypodium leucotomos extract) to protect skin structure and immune response, repair DNA and scavenge UV-induced reactive oxygen species, helping protect against sun-related effects and aging.

Angela Bowers-Plott, MD, of Southlake Dermatology, Southlake, TX, says, “The sun that’s coming through is damaging the DNA every day; a little bit here and there adds up. [Heliocare] helps correct sun damage that’s occurring past the sunscreen stage. The great thing about a systemic sunscreen is that it doesn’t miss a spot.”

Joel L. Cohen, MD, of AboutSkin Dermatology, Denver, CO, recommends Heliocare to his patients who experience more 300 days of sunshine each year compounded by high-altitude (increasing UV penetration). “I recommend Heliocare; studies have shown that this fern extract has a high affinity for skin. I have my patients take one capsule every day and an additional capsule when they’re in the sun for extended periods of time...especially patients who’ve had skin cancer or a family history of skin cancer,” Dr. Cohen states.

Biopelle, Inc., is the aesthetic subsidiary of the Ferndale Pharma Group.

Roche Seeks Approvals for New Skin Cancer Drug and Diagnostic Test

Roche submitted a New Drug Application for vemurafenib (RG7204, PLX4032) to the FDA and a Marketing Authorization Application to the European Medicines Agency (EMA) for approval for people with BRAF V600 mutation-positive metastatic melanoma. The Swiss-based company also submitted an application for the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic.

Vemurafenib, a “BRAF-inhibitor,” is designed to selectively target and inhibit a mutated form of the BRAF protein found in about half of all cases of melanoma.

The submissions are based on results from two positive clinical studies (BRIM2 and BRIM3) that evaluated vemurafenib in people with BRAF V600 mutation-positive metastatic melanoma, as determined by the investigational companion diagnostic test also being developed by Roche. A Premarket Approval Application for the cobas 4800 BRAF V600 Mutation Test was submitted in the United States. The test will also will also be registered in Europe.

PharmaDerm Introduces AK Connect

To provide physicians who treat patients with actinic keratoses (AKs) a resource to help better inform patients about diagnosis, symptoms and treatment options for AK, PharmaDerm, a division of Nycomed US Inc., launched a new online patient resource program called AK Connect (www.solaraze.com/akconnect). The company says this provides patients with an additional tool to help better inform them about this potentially serious skin condition, the importance of staying on therapy if diagnosed with AK and helpful information on protecting the skin from AK lesions.

Optical Coherence Tomography Honored as Monitoring Method for PDT Treatment of BCC

Apresentation by the Dermatology Departments at Roskilde & Gentofte Hospitals, Copenhagen, which documents how Optical Coherence Tomography (OCT) can monitor the effectiveness of PDT treatment on superficial basal cell carcinomas (BCCs), received one of 10 gold awards from the Congress Scientific Committee at the 22nd World Congress of Dermatology.

The study performed on BCC patients describes the OCT morphology in non-melanoma skin cancer (NMSC) lesions during PDT treatment and assesses how OCT morphology before, during and after treatment reflects the treatment outcome at 3 months follow-up. The investigation was carried out using the Michelson Diagnostics’ VivoSight OCT Scanner.

The main advantage of this non-invasive treatment for patients is that it avoids surgical scars. However, because no tissue is removed for analysis in the PDT procedure, it can be difficult for clinicians to be sure that they have successfully treated the tumor, and this has limited its clinical use. The study shows that the use of the VivoSight OCT scanner to image skin before, during and after PDT treatment, could solve this problem.

The VivoSight scanner uses OCT, which provides images of sub-surface tissue similar to ultrasound but at far higher resolution, enabling the clinician to see critical details of the skin epidermis and dermis in real time. Michelson Diagnostics has already obtained CE mark and FDA clearance for clinical use of the scanner in Europe and the United States, and it is being evaluated at leading cancer clinics in Europe and USA.

La Roche-Posay Expands SOS – Save Our Skin Sun Safety Initiative

La Roche-Posay recently announced the kick off of the second year of its SOS – Save Our Skin campaign with goals of informing Americans about the dangers of UV rays and the importance of sun safety, and inciting behavioral change, such as incorporating sun protection in their daily routines and visiting their dermatologists for regular skin checks. According to the company, in its first year, the SOS – Save Our Skin online campaign reached thousands of people and drew hundreds more for skin checks at a variety of events. In a third of those skin checks, suspicious lesions were found that resulted in dermatologist referrals for further investigation. This year, La Roche-Posay says it hopes to broaden its reach through viral and grassroots campaigns.

The focus of the campaign will continue to be education and skin checks. To promote education, the company will distribute more than 8,000 kits to dermatologists, which contain tools to educate patients regarding a proper skin check. The campaign will also contain a viral component, including a new iPhone application, “My UV Check,” which will provide an index for the day’s UVA and UVB exposure in the user’s location, educate and alert users of the dangers of UVA and UVB exposure and more.

Other facets of the campaign include skin checks at two New York Yankees games, as well as free skin checks being offered to all L’Oreal corporate employees. As part of the campaign’s grassroots component, La Roche-Posay will make a grant of $750,000 to the Women’s Dermatologic Society (WDS) over a 3-year period to support the WDS Play Safe in the Sun campaign.

“With skin cancer on the rise, it’s important to educate as many people as possible about the dangers of sun exposure and the importance of daily sun protection and regular skin checks. This collaborative partnership will allow us to greatly broaden our reach, which is why we’re pleased to support this WDS initiative,” said Yannick Raynaud, general manager for La Roche-Posay USA.

Play Safe in the Sun events, which began in May, will feature a “Coast to Coast” local community outreach program across 50 cities that will reach an estimated total of 25,000 people. WDS members will conduct skin checks in their local areas.

The campaign will also target professional women’s golf and tennis, as well as other outdoor non-sporting events with free skin cancer screening and sun safety education. Board-certified WDS member dermatologists will serve as volunteers at all Play Safe in the Sun events, where skin checks will be offered to all participants.

Additionally, La Roche-Posay will provide thousands of Anthelios sunscreen samples per year to be distributed at events. Educational materials containing information on sun safety practices will also be distributed.

For more information on the program, visit www.SOSsaveourskin.com or www.facebook.com/LaRochePosayusa.