New Rosacea Classification System
The National Rosacea Society Unveils New Guidelines

For a dermatological disease that is often misunderstood but affects more than 14 million Americans, the new rosacea classification system released by the National Rosacea Society organizes and explains many common misconceptions.
Recently published in the April issue of the Journal of the American Academy of Dermatology, the classification system was developed by a consensus committee that included a panel of leading dermatologists from the United States and abroad. The guidelines identify primary and secondary characteristics of rosacea, emphasizing that most patients have some but not all of the features. Rosacea’s patterns of signs and symptoms are broken down into specific subtypes described within the new system.
The chairman of the consensus committee, Dr. Jonathan Wilkin, summarized, “The new standard classification system should help broaden the utility of future research as well as aid in the clinical diagnosis of this complex disorder.”
Here’s a breakdown of the primary and secondary features that are often associated with rosacea as found in the new guidelines. Any appearance of one or more of these characteristics is indicative of rosacea.
Primary Features:
• Flushing or transient erythema (redness)
• Persistent or non-transient erythema
• Papules
• Pustules
• Telangiectases.
Secondary Features:
• Burning or stinging
• Plaque
• Dry appearance
• Swelling
• Ocular manifestations
• Peripheral location and phymatous changes.
The classification system has divided patterns of signs and symptoms into four subtypes, which include:
Subtype 1: Erythematotelangiectatic rosacea
This subtype includes swelling, stinging or burning, roughness, scaling and a history of flushing in patients. The central portion of the face is noted by flushing and persistent erythema. Telangiectases is common but not essential.
Subtype 2: Papulopustular rosacea
This subtype has been seen in conjunction with subtype 1 and features transient papules or pustules with persistent facial erythema. Burning or stinging may occur as well as the presence of telangiectases. This subtype resembles acne vulgaris minus the comedones.
Subtype 3: Phymatous rosacea
Subtype 3 occurs in a combination with the previous subtypes and includes thickening of the skin, irregular nodularities and enlargement of the nose and possibly other locations such as the chin, ears, cheeks and forehead. Subtype 3 sufferers may experience telangiectases or have large follicles affected.
Subtype 4: Ocular rosacea
Patients with this subtype experience light sensitivity, dryness, itching and burning or stinging, and the eyes may take on a bloodshot or watery appearance. Sties are common in patients with ocular rosacea and some have decreases in visual acuity due to corneal complications. An ophthalmological approach may be needed for treatment because of the potential for vision loss with this type of rosacea.

Relief For Infant Eczema
Pimecrolimus Cream Is an Effective Treatment
Parents of infants with eczema have been limited in their treatment options — until now. A new study presented at the Society of Investigative Dermatology congress in Los Angeles, CA, reported that Elidel Cream 1% (pimecrolimus) demonstrated better long-term control of eczema in infants versus traditional methods such as emollients and reactive topical corticosteroids. In a 12-month study, 251 children between the ages of 3 months and 23 months were treated with Elidel or conventional treatment. Infants treated with Elidel remained flare-free for 12 months (57%) — twice as high as the conventionally treated group of infants (28%). According to the data presented, only 36% of infants in the Elidel group required a steroid over the course of the study compared to the 65% requiring a steroid in the conventional treatment group. The results indicated Elidel, manufactured by Novartis Pharmaceuticals, significantly reduced dependence on topical corticosteroid use and provided effective long-term control of eczema.

FDA Advisory Hearing On Biologic Psoriasis Drug
New Biologic Drug Receives FDA Panel Approval
In a pioneering move that will affect the future of biologic drugs, an FDA panel voted in late May to recommend approval for the new psoriasis drug, Amevive (alefacept).
Alice Gottlieb, M.D., Ph.D., a lead researcher for the drug Remicade (infliximab), another immuno biologic agent, says she’s “pleased with the panel’s decision” and is “very optimistic” both Amevive and Remicade will receive FDA approval. “Biologics offer safe and effective hope for patients with moderate to severe psoriasis,” Dr. Gottlieb says.
Amevive, manufactured by Biogen, faces approval later this year or early next year, despite strong safety concerns by some physicians about the drug’s killing of immune-system cells.
The controversial vote that recommended approval of Amevive will continue to be closely monitored by the biotechnology sector because of this significant side effect. A number of panel members at the hearing pointed to the example of the one patient who contracted lymphoma while taking the drug. The patient’s lymphoma mimicked a similar cancer found in monkeys when given the drug in high doses. On the upside, 56% of patients experienced a 50% improvement in Biogen’s clinical trials with Amevive and positive results lasted an average of 7 months. An injection of Amevive was given to 1,357 psoriasis patients for 12 weeks. Amevive appeared less toxic than traditional treatments for psoriasis such as the cancer drug, methotrexate, or the immune-suppressant, cyclosporine. The FDA panel advised doctors to stop treatment of the drug if a patient’s immune-system cell count drops too low. It also recommended careful monitoring of patients. Experts assembled at the hearing suggested asking Biogen to establish a patient registry that monitors any safety problems after the medication is on the market.
Results from a NPS Foundation Survey
With FDA approval of Amevive, the biotechnology sector hopes a new wave of biologic drugs to treat psoriasis will be ushered in. Biologic drugs such as Amevive and Remicade are psoriasis patients’ newest hope in improving their mental and physical health. Patients with psoriasis can suffer a severe decline in quality of life, resulting in harmful, sometimes fatal, psychological effects.
According to recent survey data presented by the National Psoriasis Foundation (NPF), of the 4.5 million Americans suffering from psoriasis, the most serious psychological problems occur among the 1.5 million people with moderate to severe psoriasis.
In conjunction with Opinion Research Corporation International, Market Facts, Robinson Research, Inc., and LaunchBox, LLC, the NPF surveyed 27,000 psoriasis patients via telephone to determine the severity of their disease. Some highlights from the survey included:
• 75% said their psoriasis is a moderate to large problem in their life
• 26% altered or stopped their normal daily activities
• 40% said their psoriasis affects their clothing choices — forcing them to cover up in order to hide their condition.
• 36% said psoriasis interferes with their sleep
• 33% are very unsatisfied with current treatments
• 78% don’t use the more aggressive therapies to treat their disease because of side effects and lack of effectiveness.
Step into my skin
The NPF has launched a new campaign to educate patients about the latest class of drugs for psoriasis, biologics, and to raise awareness of the disease. The campaign, Step into My Skin, will be a resource to learn more about newest breakthrough treatments — like biologic therapies — that target the immune system to stop the progression and symptoms of psoriasis. To order the educational kits for your patients call the toll-free hotline at (888) 236-4500. Patients looking for more information about psoriasis can check out the NPF’s Web site at www.psoriasis.org.

New Approvals
Generic Corticosteroid-Responsive Dermatoses Approval
Fougera recently received approval for the generic Desonide Lotion 0.05% to relieve corticosteroid-responsive dermatoses. The lotion is AB-rated to DesOwen, manufactured by Galderma. Fougera, a division of Altana, Inc., also received approval for the AB-rated, Desonide Ointment 0.05% presentation. Production on the ointment will begin within a few weeks.

New Labeling for Imiquimod Cream
3M Pharmaceuticals recently announced a change in the labeling of its Aldara Cream 5% for the treatment of external genital warts. The cream is now indicated for patients 12 and older. It had previously been indicated for patients 18 and older. Data submitted to the FDA by 3M on Aldara’s effectiveness and safety in adolescents prompted the change in labeling. 3M, based on FDA allowance, also revised the clinical information regarding Aldara’s mechanism of action to include additional benefits of the cream. According to 3M data, clinical trials showed that Aldara helped the body combat the human papillomavirus (HPV) that causes genital warts. Studies also found Aldara to be active throughout skin tissue where the virus is more likely to be found.

OTC Loratadine Backed by FDA Advisory Committee
The non-sedating antihistamine, Claritin, received backing from an FDA advisory committee as an over-the-counter (OTC) treatment of chronic idiopathic urticaria or hives. The unanimous decision by the committee based its support on the need for a non-sedating OTC option. Manufactured by Schering-Plough, Claritin is currently available as a prescription therapy for seasonal allergies and hives. If Claritin receives FDA approval it would be the first non-prescription, oral antihistamine available in the United States for chronic hives.

Wound Gel Approved
LAM IPM, a topical wound gel, can now be marketed to treat a variety of ailments from minor cuts to diabetic ulcers. LAM IPM, manufactured by LAM Pharmaceutical Corp., received FDA approval for over-the-counter sales to treat abrasions and minor cuts. Under a healthcare professional’s supervision, the gel can be used to treat pressure ulcers, leg ulcers, diabetic ulcers and for the management of surgically or mechanically debrided wounds. According to data presented by LAM, the wound gel showed an “88% effectiveness in creating the necessary environment for wound healing of refractory leg and foot ulcers.” LAM IPM contains an ionic polymer matrix that delivers doses of sodium hyaluronate, believed to optimize tissue repair.

Advanced Dressing for Chronic Wounds
The FDA has approved a unique combination of a chronic wound dressing. From Johnson & Johnson Wound Management, the Promogran Matrix Wound Dressing combines 45% oxidized regenerated cellulose (ORC) with 55% collagen to treat exuding wounds such as diabetic, pressure and venous ulcers. ORC and collagen create a moist, wound-healing environment that, according to Johnson & Johnson Wound Management, is conducive to new tissue growth.

CDC’s New Campaign
Overcoming Antibiotic Resistance
Everyone is aware of the growing concern surrounding antimicrobial resistance, but changing prescribing and treatment behavioral patterns is easier said than done.
The Centers for Disease Control and Prevention (CDC) hopes to arm healthcare providers, facilities and patients with tools to combat antimicrobial resistance. Appropriately named, the “Campaign to Prevent Antimicrobial Resistance” will focus on four steps:
1. preventing infection
2. diagnosing and treating infection effectively
3. using antimicrobials wisely
4. preventing transmission.

Using evidence-based guidelines and recommendations, the CDC developed a tool for healthcare providers — “12 Steps to Prevent Antimicrobial Resistance: Hospitalized Adults.” These guidelines are available as posters, pocket cards, Web presentations and more. To view the materials and learn more about the campaign, visit: http://www.cdc.gov/drugresistance/healthcare. CDC is working on similar tools targeting pediatricians, surgeons, geriatricians, emergency physicians and others.

In Brief...
Healthpoint Acquires Oasis Marketing Rights … Healthpoint and Cook Biotech Inc. recently announced an exclusive agreement that allows Healthpoint to market Cook’s wound matrix product, Oasis. Cook will continue to manufacture the product while Healthpoint will market it in the United States.

Lupus Deaths on the Rise … In a recent CDC study, published in the Morbidity and Mortality Weekly Report, systematic lupus erythematosus (SLE) deaths have risen in a 20-year period. SLE deaths rose from 39 to 52 per million. The death rate is 3 times higher among blacks than whites and 5 times higher for women. Death figures among black women 45- to 64-years-old has increased 70% in 20 years, according to the study’s data.

Connetics Set to Establish New Derm Residency Program … Connetics Corp. has announced its plan to establish a dermatology residency program at Stanford University School of Medicine. The program is slated to begin in July 2003. Interested dermatology residents will rotate through varying departments of the company to learn about clinical programming, drug research, development and commercialization processes. Derm students will have the opportunity, if they choose, to spend several months at Connetics during their residency program to conduct basic research or participate in clinical research.

Licensing Rights of Velac Gel … Connetics Corp. recently announced it will license Velac gel, a combination of 1% clindamycin and 0.025% tretinoin. Connetics has partnered with Yamanouchi Europe B.V. to develop and commercialize the gel in the United States and Canada.

Status on 510K Clearance Announced by Lumenis … Awaiting 510K clearance on its ClearLight Acne Photoclearing System, Lumenis has provided additional data as clarification to the FDA. Lumenis hopes its system becomes a first line of treatment for inflammatory acne.

Fujisawa’s Eczema Drug Now Available in U.K … The atopic eczema drug, Protopic (tacrolimus ointment), manufactured by Fujisawa, is now on the market in Great Britain. As a non-steroidal treatment alternative to conventional therapies, Protopic is safe for patients age 2 and older with moderate to severe eczema. In a press conference held in London, dermatologists noted improvement in 70% of patients treated with Protopic.