Main Issue November 2011

Recent Developments

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Research Updates & News

Demographic Patterns in Pediatric Psoriasis

Findings from a new study suggest that pediatric psoriasis is vastly undertreated in certain patient demographics (Arch Dermatol. e-pub Sep 19). Investigators used survey data over a 28-year period to characterize patterns of childhood psoriasis. Of the estimated 3.8 million patient visits for pediatric psoriasis, 93 percent of patients were white and a majority was over the age of eight. Topical corticosteroids were the most commonly prescribed medications for treatment of pediatric psoriasis. Children zero to nine years old received equally potent corticosteroids as children 10 to 18 years old. Topical calcineurin inhibitors were not among the top 20 most prescribed medications by dermatologists, and systemic agents were not among the top 20 most prescribed medications in any age group. The researchers concluded that treatment guidelines for childhood psoriasis may help reduce treatment variability.

Topical Antibiotic Prescribing Trends Uncovered

While prescribing for topical antibiotics appears to be decreasing among dermatologists, it seems to be on the rise among non-dermatologists. These trends—which do not achieve statistic significance— are evident in an analysis of antibiotic use data from the 1993 to 2007 National Ambulatory Medical Care Survey. Topical antibiotic use was analyzed according to patient demographics, diagnoses, procedures, concomitant medications, and provider specialty.

The most frequent diagnoses associated with topical antibiotic use are benign or malignant neoplasm of skin, impetigo, insect bite, and cellulitis. Use of topical antibiotics in association with dermatologic surgery decreased significantly over the analyzed period; use in conjunction with skin biopsies decreased non-significantly.

Overall, the authors conclude, topical antibiotics continue to be used for non-evidence-based indications, causing concerns about detrimental effects on patients and significant costs to the health care system. Findings appeared online in Dermatologic Surgery.

Botanicals May Have Ovicidal Effects Against Lice

Some botanical-based agents may have better than expected ovicidal efficacy, but a suffocation agent appears to offer greatest efficacy for lice, according to results of a trial designed specifically to measure ovicidal rather than lousicidal efficacy.

Ninety-two subjects with at least 20 live eggs of Pediculus capitis were randomised to one of three treatment groups: a melaleuca oil or tea tree oil and lavender oil pediculicide; a eucalyptus oil and lemon tea tree oil pediculicide; or a "suffocation" pediculicide.

First, 10 to 22 live eggs were taken from the head of each subject by cutting single hairs with the live eggs attached. Next, each subject received a single treatment of one of the three pediculicides, according to the manufacturers' instructions. Post-treatment, 10 to 41 treated live eggs were taken from the head by cutting the single hair with the egg attached. All collected eggs were incubated for 14 days and the proportion of eggs hatched in the pre-treatment group was compared with the proportion of eggs that hatched in the post-treatment group.

Eucalyptus oil and lemon tea tree oil had an ovicidal efficacy of 3.3 percent; melaleuca oil and lavender oil had an ovicidal efficacy of 44.4 percent; and "suffocation" pediculicide had an ovicidal efficacy of 68.3 percent. Findings appear in BioMed Central’s BMC Dermatology.

FDA Reviewing Oral Contraceptives Used for Acne

With studies offering conflicting evidence about the influence of drosperinone-containing oral contraceptive pills (OCPs) on a woman’s risk for venous thromboembolism (VTE), FDA will convene an advisory panel next month to review the safety of Yaz (Bayer) and similar formulations that have become popular for the treatment of acne. According to the agency, it is unable to draw a conclusion about the safety of the medications without input from members of the reproductive health and drug safety advisory committees.

At issue are studies published this year in British Medical Journal that suggest that OCPs containing the synthetic progestin may double or triple a female patient’s clotting risk. Other studies have failed to demonstrate any increased risk associated with the drugs. Unlike progestin, which can be associated with androgen-like activities (progestin-containing OCPs remain overall anti-androgenic), drosperinone has no androgenic activity and is in fact an analog of the widely used systemic anti-acne agent spironolactone. As such, formulations containing drosperinone have been a particularly popular choice for female patients with acne who are also candidates for oral contraceptive therapy.

While some clinicians and many patients have expressed concern about FDA’s decision to review the agents, dermatologist Julie Harper, MD says that the action itself need not cause anxiety about the future of the drugs. “This is the culture that we live in,” Dr. Harper says. “The FDA has to err on the side of being extraordinarily cautious.” The decision to review the safety of the drugs, “may be wise,” she says, though she adds that she hopes the agency interprets study findings accurately and wisely. If no significant risk is found, patients and prescribers can be reassured. “If there is anything found, I hope that they do put that identified risk in context,” she says.

Many popular media reports about the possible risk for VTE may be confusing for patients and some prescribers by stating that drosperinone-containing OCPs may triple a woman’s risk for VTE. According to Dr. Harper, the overall incidence of VTE in any woman is three per 10,000 women per year. With conventional OCPs, the incidence may be as high as six or seven per 10,000 women per year. If the studies on drosperinone are correct, the incidence of VTE associated with the agent is nine or 10 per 10,000 women per year. One of the challenges in determining the validity of studies is variability in study design, which makes it difficult to compare findings from one cohort to another.

Dr. Harper also reminds that there are known risk factors associated with an increased risk for VTE in women using OCPs. Increased BMI, recent surgery, or immobilization all increase a woman’s risk for VTE.

FDA Advertisement Guidelines Rarely Followed

New research suggests that advertising from the pharmaceutical industry may not comply with FDA guidelines. A study of 192 pharmaceutical advertisements in biomedical journals found that only 18 percent were compliant with FDA guidelines, and over half failed to quantify serious risks including death (Public Library of Science One). Researchers performed a cross-sectional analysis of prescription pharmaceutical advertisements published in nine journals in November 2008. They evaluated adherence to FDA standards and the presence of content that is important for physicians to use when safely prescribing the drugs. Of the 192 advertisements for 82 unique products, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines. In addition, 57.8 percent of the advertisements did not quantify serious risks, 48.2 percent lacked verifiable references, and 28.9 percent failed to present adequate efficacy quantification.

Tanning Bed Use Minimum Age Raised to 18 in CA

The legal age for tanning bed use in the state of California has gone from 14 to 18 years, after Governor Jerry Brown signed a new bill into law. Previous to the law, individuals aged between 14 and 18 were allowed to use tanning salon services if they had permission from their parents. This marks the first occasion of a state banning anyone under the age of 18 years from using ultraviolet tanning beds and devices in commercial premises. The new law (SB 746) was sponsored by the California Society of Dermatology & Dermatological Surgery and the AIM at Melanoma Foundation and will go into effect on January 1, 2012.

Cultural Conditions Influence Acne

A new publication examines how the treatment of acne vulgaris often can be affected by individual patient characteristics, including skin color and cultural background. The investigators note that skin of color is especially prone to hyperpigmentation, both from acne lesions and from irritating acne-targeted therapy. They also emphasize the importance of cultural attitudes and folk remedies that may adversely affect dermatologic conditions such as acne. (Semin Cutan Med Surg. 30(3 Suppl):S12-5.)

Fractional Therapies Found Effective for Acne Scars in Ethnic Skin

Non-ablative fractional (NAF) 1,550nm and ablative fractional (AF) CO2 Lasers are effective in the treatment of acne scars in ethnic skin. Thirtyfive percent of patients receiving NAF therapy and 37 percent of patients receiving AF therapy attained more than 50 percent improvement in scarring. Investigators concluded that both NAF 1,550nm and AF CO2 lasers are effective in treating acne scars in ethnic skin with good patient satisfaction rate and high safety profile. Moreover, they noted that fractional laser resurfacing opens a wide horizon for treating acne scars in ethnic skin. (Lasers Surg Med. 43(8):787- 91)

Glycolic Acid Emulsion Effective For Mild Acne?

An oil-in-water emulsion-containing 10% glycolic acid (pH 4; Dr. August Wolff GmbH & Co. KG Arzneimittel, Bielefeld, Germany) may be an effective agent in treating mild acne, according to a new report. Acne improved significantly in patients receiving the agent for up to 90 days after treatment, with some patients responding at 45 days. Regarding tolerability, investigators noted that there was was no objective or subjective difference between the 10% glycolic acid containing oil-in-water emulsion and corresponding placebo. (J Cosmet Dermatol.10(3):202-9)

Combo RF Device May Be Beneficial for Acne Scars

A novel device with a handpiece combining optical and radiofrequency (RF) energies along with a fractionated RF handpiece may be a useful device for nonablative resurfacing. Researchers evaluated the improvement in acne scars and skin texture in patients who received five treatments at 30-day intervals. They observed a 72.3 percent decrease on the acne scar scale from day 1 to day 210. From day 30 to 210, investigator-rated changes in scarring, texture, and pigmentation improved 68.2 percent, 66.7 percent, and 13.3 percent, respectively. Patient satisfaction scores showed no significant change over time, although patient-evaluated overall improved scores increased 60 percent over baseline. (Dermatol Surg. e-pub Aug 11)

Adherence Improves with Knowledge

Researchers studied acne patients in Japan to determine the likelihood of good adherence and found that satisfaction with treatment and the experience of side effects had an impact on adherence. Patients who felt they had a good understanding of acne and its treatment were more likely to have good adherence. (Dermatology, e-pub Oct. 21)

No Degradation for Tretinoin

In vivo data presented at the annual meeting of the AAD shows that Atralin (tretinoin, Valeant) Gel 0.05% may not degrade on contact with benzoyl peroxide. When tretinoin was mixed with benzoyl peroxide, there observed no significant loss of tretinoin over a seven-hour time period, Valeant reports.

Product News

Hydration Delivered

Eraclea recently launched its new, hydrationfocused line of skin care products based on the HylaSponge System. The new line includes Intensive Repair and Protect Serum/Vitamin C to protect against cell damage and improve tone and texture; Eye Surround Cream, which they say minimizes the appearance of fine lines and wrinkles; and Intensive Hydrating Day Cream, which supplies the skin with nutrients, peptides, and antioxidants. eracleaskincare.com

Skin Is In LaunchesDermatologist Tina Alster, MD recently launched Skin Is In, a new skincare line offering easy-to-use kits for people of all ages. The line includes the k.Zone for Kids, t.Zone for Teens, FaceTime for Women, FaceTime for Men, d.Sensitize for Sensitive Skin, and i.Rejuvenate for Eyes. SkinLaser.com/SKINISIN

Non-Steroidal Balm Available

ExtremeSkinCare Intense Treatment Balm is a new non-steroidal treatment that helps reduce the appearance and effects of psoriasis, eczema, and other difficult skin conditions, the maker says. With high concentrations of peptides, polysaccharides and botanical emollients that soothe, nourish and soften rough, damaged skin, ExtremeSkinCare Treatment Balm increases the skin’s resistance to further physical damage by 60 percent in 14 days, according to its manufacturer. Skinhealthtech.com

New Barrier Cream Available

Incorporating hyaluronic acid and a blend of physiologic lipids, including ceramide, new HylatopicPlus Cream from Onset Dermatologics is now available. HylatopicPlus Cream is formulated to rapidly hydrate the stratum corneum and provide a semi-permeable barrier that protects against irritants and excessive water loss through the skin, Onset says. The new cream formulation joins the existing HylatopicPlus Foam formulation. OnsetDermatologics.com

Effaclar Goes National

LaRoche’s popular Effaclar Duo dual action acne treatment is now available at CVS Pharmacy stores nationwide. According to the company, Effaclar Duo effectively reduces inflammatory and noninflammatory acne lesions and has demonstrated optimal tolerability. Preliminary results of an ongoing study show that Effaclar in combination with a topical retinoid resulted in a 70 percent reduction in overall lesion count after eight weeks, the company reports. Laroche-posay.us

Acne Prevention Kit Available

For patients focused on acne prevention, consider ZO Skin Health’s new Acne Care and Prevention Kit. The kit contains four products, including the Offects Exfoliating Cleanser, which targets excess oil and reduced sebum production; the Offects Exfoliating Polish, for removing buildup and increasing epidermal turnover; the Offects TE-Pads, to sweep away excess oil and dead skin cells; and the Bio-Sulfur Masque, a paste for overnight use that slows sebum activity, breaks down sebum on the skin’s surface, and provides anti-inflammatory and anti-bacterial benefits to keep complexion healthy and clear, according to the company. Zoskinhealth.com

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