Recent Developments

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More Than Skin Deep?
New research suggests that the development of eczema goes deeper than epidermal barrier function. Data indicate that a second skin barrier structure consisting of cell-to-cell connections known as tight junctions likely plays a role in the development of eczema (Journal of Allergy and Clinical Immunology). Researchers studied skin samples from eczema patients and healthy individuals using resistance and permeability tests. They discovered that tight junctions, which act like a gate controlling the passage of water and particles, were strong and tight in healthy skin samples, but loose and porous in the skin of eczema patients. On further investigation, they found that a particular tight junction protein, claudin-1, which determines the strength and permeability of tight junctions in skin, is significantly reduced in the skin of eczema patients, but not in healthy individuals or individuals with psoriasis. The researchers plan to investigate the immunologic consequences of tight junction disruption in the skin and whether there is a relationship between barrier disruption and patients' intractable itch.

Lice Treatment in the Pipeline
Current treatments for head lice tend to be limited, but an investigational agent may soon be available to treat dry hair and scalp in young and old patients. Topaz announced the completion of two Phase 3 clinical trials studying the use of ivermectin topical cream whose mechanism of action is through selectively binding to certain ion channels present in the invertebrate nerve and muscle cells. The studies compared 0.5% ivermectin cream with vehicle in patients six months of age and older. The primary efficacy endpoint was achieving “lice free” status within approximately 24 hours of application and maintaining this status for at least 14 days after application. Topaz plans to submit its NDA to the FDA in 2011.

Heads Up
New data suggest that the two-compound scalp treatment calcipotriol and betamethasone (Taclonex Scalp, Leo) has a rapid onset of action and yields significant efficacy after just one week (Journal of the European Academy of Dermatology & Venereology 25:1). Researchers analyzed pooled data from two large pivotal phase 3 trials with 2,920 patients receiving once-daily treatment for up to eight weeks with either the two-compound scalp formulation, betamethasone dipropionate, calcipotriol, or vehicle. Findings show that 30.6 percent of patients who were treated with the two-compound formulation had absent or very mild disease after one week of treatment, compared to 24.1 percent of those treated with betamethasone, and 10 percent of those treated with calcipotriol.

Supreme Court May Hear Case on Side Effects of Generic Drugs
In the coming year, the US Supreme Court is expected to decide whether generic drug companies could be sued under state law over allegations that they failed to provide adequate label warnings about side effects. Controversy exists on the issue because the drugs in questions have been approved the FDA and thus may be subject to federal law. The Supreme Court decided a related case involving the Wyeth anti-nausea drug Phenergan in 2009, when it ruled that FDA regulations do not protect pharmaceutical companies from being sued under state law over drug labeling. The Court is expected to hear arguments in the generic drug cases in March or April, with a decision likely by the end of June, Reuters reports.

Botox May Improve QOL and Self Esteem
Patients who receive botulinum injections may experience improved quality of life (QOL) and selfesteem, according to a new study (Dermatologic Surgery, November 2010). Researchers evaluated 100 patients who received treatment with botulinum toxin A (BoNTA) or placebo saline. The patients then completed a health outcomes survey consisting of Quality of Life Enjoyment and Satisfaction Questionnaire–Short Form and Heatheron and Polivy State Self Esteem measurements before injection and two weeks and three months after injection. Statistically significant improvements were observed in patients treated with BoNTA in answers to QOL questions regarding physical health, mood, household activities, overall life satisfaction, body satisfaction, self-consciousness, intellect, self-worth appearance, comprehension, weight satisfaction, attractiveness, and sense of well-being.

Systemic Psoriasis Therapies May be Under-used
A recent online survey of patients with moderate to severe psoriasis reveals systemic therapies may be underutilized, given the high rates of dissatisfaction with topical therapies (International Journal of Dermatology 49: 12). Patient awareness of available treatment options ranged from 98 percent for prescription topical agents to 75 percent for photo/light therapy, and was less than 50 percent for prescription oral (49 percent) and injectable (35 percent) medications. Of the 514 patients surveyed, 92 percent had been treated with and 61 percent were currently taking prescription topical agents. Photo/light therapy had been used by 38 percent and was currently used by seven percent of respondents. Prescribed oral medication had been taken by 25 percent and was currently used by eight percent. Few patients had been treated with injectables in the past (10 percent) or currently (five percent). Overall, 24 percent of respondents were very satisfied with their current treatment. A total of 63 percents of respondents taking injectables were very satisfied, compared with 38 percent of those taking prescribed oral medication and 21 percent of those receiving photo/light therapy. The researchers indicated that treatment satisfaction rates were overall low, highlighting the need to ensure greater patient education on and use of available therapeutic options.

New Acne Findings in Women with PCOS
High serum dehydroepiandrosterone sulfate (DHEAS) is associated with acne and a reduced risk of abdominal obesity in women with polycystic ovary syndrome (PCOS), new research suggests (Human Reproduction, November 2010). Researchers evaluated 318 consecutive untreated Taiwanese women with PCOS, recording phenotypic hyperandrogenism, BMI, waist circumference, wait-to-hip ratios, lipid profiles, fasting glucose and insulin levels, and hormone profiles. Women with acne were younger, had higher serum DHEAS levels and a lower BMI, but comparable serum testosterone levels, compared with women without acne. The aggravating effect of elevated DHEAS on the risk of acne still exited after adjustment for age and BMI. The DHEAS level was positively correlated with the testosterone level, but inversely related to waist circumference, wait-to-hip ratio, BMI, IR index, low-density lipoprotein-cholesterol and triglycerides.

Take a Supplement
Maintaining adequate levels of vitamin D while practicing photoprotection to protect from skin cancer has developed into an ongoing debate among various medical disciplines. A new review suggests that while this is a valid concern, assessing vitamin D status and administering vitamin D supplementation when needed can mitigate it (Seminars in Cutaneous Medicine and Surgery 29: 3). The authors report that patients who took vitamin D oral supplementation had greater serum 25(OH)D levels than those who did not, whereas dietary intake through foods did not predict 25(OH)D levels. Nonetheless, there was still a high prevalence of vitamin D insufficiency and deficiency in the patient population, highlighting the importance of assessing vitamin D status and recommending oral vitamin D supplementation when indicated.

To Your Health?
Even moderate intake of non-light beer appears to increase a woman's risk for psoriasis, data show (Arch Dermatol 146(12):1364-1369). Based on analysis of data from the Nurses' Health Study II, which followed a cohort of 116,671 US women, the multivariate relative risk of incident psoriasis among women who have 2.3 drinks or more per week is 1.72 compared to nondrinkers. Although consumption of five or more non-light beers is associated with increased psoriasis risk, consumption of light beer, red wine, white wine, and liquor is not significantly associated with psoriasis risk.

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