Recent Developments

Research Updates

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.
An investigational agent may soon be available to treat lice in the dry hair and scalp of 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 involves 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.

Short-contact BPO Foam Reduces P. Acnes.
A new study presented at the Fall Clinical Dermatology Conference in Las Vegas shows that benzoyl peroxide 9.8% foam when used in a short contact regimen reduces P. acnes populations on the back. In a two-week, open-label study, 20 patients were treated once daily for two weeks with BPO 9.8% foam (BenzEFoam Ultra, Onset Therapeutics), applied to skin and left in place for a period of time then washed off. Mean reduction of P. acnes counts on the back was 0.91 log per cm² after one week of treatment, and 1.66 log per cm² after two weeks, equivalent to a 98.3 percent reduction. Researchers noted that short-contact BPO (9.8%) foam is especially effective with two minutes of skin contact time and that application to non-moistened skin may allow for longer BPO skin contact time between application and rinsing than is achieved with a BPO cleanser.

Eczema Prevalence Linked to Daycare.
Children who spend their earliest years in daycare may be at higher risk of eczema than kids cared for at home, according to a new German study (Allergy). Since previous studies have indicated that eczema is more common among children who attend daycare, investigators examined whether being in daycare before age two, along with several other potential risk factors, influenced eczema risk. They followed 3,097 children from birth to age six. Results showed that early daycare attendance was the only factor independently associated with eczema risk. Children in early daycare were 56 percent more likely to have the skin condition than children who didn't attend daycare before age two. The effect seemed to weaken as children got older. While the study didn't look at why early daycare could increase eczema risk, the researchers say that in daycare children may be exposed to more allergens and microorganisms than at home. Children in daycare also could be more stressed, which could promote the development of eczema.

A Tan You Can Endorse.
Use of sunless tanners and skin cancer education may decrease the amount of time individuals spend in the sun…at least for a while, a new study suggests (Arch Dermatol. e-Pub September). Researchers tested whether offering sunbathing women free samples of self-tanning lotion and sunscreen could heighten awareness of the harms of UV. They set up a tent on a beach and invited 250 women in. Half of the beachgoers got free cosmetics samples unrelated to skin health, while research assistants—selftanned, but without financial ties to manufacturers— handed out sunless tanners along with a bit of skin cancer education to the others. After two months, the women given sunless tanners reported a 33 percent decrease in sunbathing, compared to 10 percent in the control group. They also got fewer sunburns and wore more protective clothing, although those effects had vanished when they were contacted one year later.

Topical Corticosteroids During Pregnancy.
Though indicated during pregnancy, questions have remained about the use of topical corticosteroids by pregnant women. A recent study in the Journal of Investigative Dermatology, “found no associations of maternal exposure to topical corticosteroids with orofacial cleft (and its two subtypes, i.e., cleft lip ± palate and cleft palate alone), preterm delivery, and fetal death (including miscarriage and stillbirth).” In contrast, “maternal exposure to potent/very potent topical corticosteroids shortly before and during pregnancy was significantly associated with fetal growth restriction (adjusted relative risk 2.08; 95% confidence interval 1.40-3.10; number needed to harm, 168),” which was validated by a significant significant dose-response relationship (P=0.025) and the sensitivity analysis omitting exposure before last menstrual period (LMP).

Researchers utilized the UK General Practice Research Database to conduct a population-based cohort study for their investigation. They identified 35,503 pregnant women prescribed topical corticosteroids during the period from 85 days before LMP to delivery or fetal death and 48,630 women not exposed to treatment.

Long-Term Tacrolimus OK in Pediatric Patients.
A new study says “treatment with tacrolimus, alone or in combination with topical corticosteroids for acute flares may be a useful option for longterm management of atopic dermatitis in pediatric patients.” Published in the September/October issue of Pediatric Dermatology (27(5):425-36), the study looked at the effect of tacrolimus ointment, a topical calcineurin inhibitor approved for patients two years of age and older.

Previous studies have shown that tacrolimus is an effective treatment for the short-term relief of symptoms in pediatric patients with AD. Also, “long-term trials have demonstrated that the effectiveness of tacrolimus is maintained for up to four years in children,” the authors note. “Additional studies have revealed that long-term intermittent use of tacrolimus as part of maintenance therapy can prevent AD flares.”

Low Bone Mineral Density Not Common in Topically- Treated AD Patients.
While low bone mineral density (BMD) has been reported in 30.4% of adult patients with atopic dermatitis (AD), the use of topical corticosteroids in the previous five years was not associated with a decrease in BMD among children with moderate to severe AD compared with the general population, according to a report in the Journal of American of Dermatology (63(5):824-31).

For the study, lumbar spine BMD was measured by dual-energy X-ray absorptiometry in 60 children five-16 years of age with moderate to severe AD. The researchers found that three patients (5 percent) had low BMD and one patient (1.7 percent) had osteoporosis, which not differ from the expected prevalence of low BMD in the general population. A slight decrease in BMD was observed among children treated with oral corticosteroids or immunomodulators, but the rate was not statistically significant.

Product News

Natroba Approved.
Natroba (spinosad) Topical Suspension 0.9% is now approved for the treatment of head lice infestation in patients ages four years and older. The safety and effectiveness of Natroba Topical Suspension 0.9% have been established in two multicenter, randomized, active-controlled studies. A total of 552 subjects received a 10-minute treatment with Natroba. If live lice were seen a week later, a second treatment was applied. The proportion of subjects who were licefree fourteen days after the final treatment of Natroba was approximately 86 percent compared to 44 percent of the control group. Common adverse events reported include redness or irritation of the eyes and skin. Safety in pediatric patients below the age of four years has not been established. Although Natroba is not approved for use in children younger than four years, it is especially important not to use in infants because the product contains benzyl alcohol. Benzyl alcohol has been associated with serious adverse reactions, including death, when applied topically to the skin of children younger than six months.

New BP Gel Coming Soon.
Glytone has unveiled Acne 3P Gel, its latest benzoyl peroxide formulation meant to fight acne without causing the common BPO side effects of dryness, flaking, and irritation.Containing 5% benzoyl peroxide and 1% polyol prepolymer, Acne 3P Gel is designed to penetrate the skin continuously, the company says,while helping to retain skin moisture. It will be available for physician dispensing beginning in February.

Pucker Up.
A quickly absorbing lip cream that provides first-aid and protection for severely dry, cracked, chapped, and flaky lips, Cold Cream lip cream contains Avene Thermal Spring Water (1%) to soften the skin, as well as Sucralfate, which helps restore the skin barrier, and a lipid cocktail including linoleic acid and shea butter, according to the company. It will be available in February 2011.

Wash and Go.
A new foam formulation of benzoyl peroxide offers a new approach to treatment of truncal acne. BenzEFoam Ultra 9.8% (Onset Therapeutics/PreCision Dermatology) provides a high concentration of benzoyl peroxide in an emollient foam base intended for quick and easy application to the trunk, including hair-bearing skin. The Delevo emollient foam technology is also featured in the original BenzEFoam formulation. Data demonstrate benefit from a shortcontact regimen in which the product is left in place for two minutes prior to rinsing and wiping off with a cloth. Marketer PreCision Dermatology, Inc. was formed in December through a spin-out of Onset Therapeutics, which is now a division of the company. The new company says it is dedicated to expanding in the market.

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